Companies / Corin Group

Medical device company profile

Corin Group

UK-based manufacturer of hip and knee replacement implants, robotic-assisted surgical systems and patient-specific planning technologies.

Medical Device ManufacturerOrthopedics & MusculoskeletalJoint Reconstruction

Headquarters🇬🇧Cirencester, Gloucestershire, United Kingdom

Founded1985

Commercial statusCommercially availableHip and knee implants and guidance systems; U.S. and international markets, with product-specific availability.

Employees501–1,000 ^[16]LinkedIn company-size range · Checked 2026-10-22

Estimated revenueNot confirmed

Official websitewww.coringroup.com ↗

Company overview

Corin Group is an orthopedic medical-device manufacturer headquartered in Cirencester, Gloucestershire, United Kingdom. Founded in 1985, it combines joint-replacement implants with surgical planning, intraoperative guidance and connected technologies. Its official contact list includes U.S. operations in Raynham, Massachusetts, and Milpitas, California.

The current U.S. catalog includes primary and revision hip and knee systems, alongside ApolloKnee, ApolloHipX, OMNIBotics and Optimized Positioning System tools. Product features, availability and regulatory scope vary by model and market. Selected product families are shown below rather than a complete global or historical catalog.

MMG Medical Sales & Services publicly lists Corin hip products, including Revival revision stems, TriFit CF and TriFit TS, Icona, Trinity and Trinity Dual Mobility. This is distributor-reported evidence; Corin-specific contractual territory, exclusivity and an active distribution agreement have not been independently established.

^{[13][14][15][17][18][19][20]}

Products & regulatory status How does MedTechIndex get this information?

Summary

The selected current families are linked to 66 FDA 510(k) decisions, including Revival revision stems, primary hip stems, acetabular systems, Unity and Apex knees, robotics and planning tools. ApolloKnee is documented under K231172 and ApolloHipX under K241808. Decisions may cover different configurations and uses; the count is not a count of products or indications. ^{[131][132][133][6]}

FDA records identify four open recall events affecting specified Unity knee components, BIOLOX Delta modular heads, a MetaFix hip stem and Apex knee instruments/components. The issues include labeling mismatches and packaging integrity. The cited records define the affected models, lots and actions; they do not establish that an entire product family is affected. ^{[134][135][137][138][141][148]}

The assembled Corin and OMNI history contains 25 distinct recall events, including terminated legacy events. Only mapped current-family events enter the scorecard. The original Cormet hip-resurfacing PMA is retained as historical and excluded from current totals. Corin/OMNI De Novo requester searches found no matching grants within that named-search scope. ^[207][134]

Regulatory snapshot How to read this snapshot

U.S. FDA

66+
510(k) clearances: 0
De Novo grants: —
PMA approvals: 17+
Recall events

Latest recorded source review: 2026-10-22.

View 4 documented open recall events

Documented open FDA recall events
Recalled product / record	Initiated	Source
Apex Knee SystemZ-2069-2025	May 23, 2025	^[148]
Unity CR Femur Right, Size 6Z-0213-2024 Unity Total Knee SystemZ-0214-2024	October 13, 2023	^[134][135]
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mmZ-0726-2023 Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mmZ-0727-2023	November 8, 2022	^[137][138]
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESSZ-1509-2022	July 22, 2022	^[141]

Commercial portfolio snapshot

Documented commercial product families.

Corin Revival modular revision hip stems — Image: Corin Group

Revision hip arthroplasty

Revival modular revision hip system ↗

Modular femoral stem system for revision hip arthroplasty and specified primary cases. FDA records include K152903 and K191374; modularity allows separate distal fixation and proximal reconstruction. ^{[1][33][85][87][131]}

FDA-cleared

Listed in Corin’s U.S. product catalog; availability and configurations vary by market.

Icona femoral stem, representative of Corin’s primary hip portfolio — Image: Corin Group

Primary hip arthroplasty

Primary hip stem portfolio ↗

Selected U.S. catalog families include Icona, TriFit CF, TriFit TS, MetaFix, MiniHip, TaperFit and Paragon HA. The image depicts Icona, a collared, triple-taper cementless stem. Each system has its own labeling and compatibility requirements. ^{[2][22][30][94][96][7]}

FDA-cleared

Established stems are marketed in the U.S.; Corin describes Icona as a limited market release.

Corin Trinity dual-mobility hip construct, representative of the acetabular family — Image: Corin Group

Hip arthroplasty

Acetabular systems and hip bearing components ↗

Trinity, Trinity PLUS, Trinity Dual Mobility and MobiliT cups and associated bearing components support hip reconstruction. The image depicts a Trinity dual-mobility construct. Compatibility and cleared configurations differ by model. ^[3][61][6]

FDA-cleared

Listed in Corin’s U.S. product catalog; availability and configurations vary by market.

Corin Unity femoral and tibial knee components — Image: Corin Group

Total knee arthroplasty

Unity Total Knee System ↗

Primary and revision knee components, with multiple insert and femoral configurations. FDA records include later medial-constrained, PS-C and cementless configurations. Authorization must be read against each device’s specific labeling. ^{[4][88][106][8]}

FDA-cleared

Listed in Corin’s U.S. product catalog; availability and configurations vary by market.

Apex primary knee construct, representative of the primary and revision knee family — Image: Corin Group

Knee arthroplasty

Apex primary and revision knee systems ↗

Apex primary knee and Apex Revision systems are listed in Corin’s U.S. catalog. FDA history includes the OMNI Life Science applicant lineage. The image depicts a primary Apex construct. ^{[5][110][126]}

FDA-cleared

Listed in Corin’s U.S. product catalog; availability and configurations vary by market.

Official Corin illustration of its knee robotics workflow — Image: Corin Group

Robotic-assisted knee surgery

ApolloKnee and OMNIBotics ↗

Corin’s knee robotics portfolio includes ApolloKnee, the Apollo platform with BalanceBot assessment and robotic guidance, and the earlier OMNIBotics system. FDA records separately identify ApolloKnee and OMNIBotics; their names do not establish authorization for autonomous surgery. ^{[9][97][102][130][132]}

FDA-cleared

Listed in Corin’s U.S. product catalog; availability and configurations vary by market.

View 2 additional documented product families

Hip surgical guidance

ApolloHipX ↗

An Apollo application integrating 3D preoperative planning with intraoperative fluoroscopic validation for total hip arthroplasty. FDA K241808 cleared ApolloHipX on January 7, 2025. The depicted equipment and software support the defined guidance workflow. ^{[10][103][133]}

FDA-cleared

Listed in Corin’s U.S. product catalog; availability and configurations vary by market.

Corin OPS patient-specific hip planning illustration — Image: Corin Group

Surgical planning and analysis

OPSInsight and OPSReView ↗

Optimized Positioning System tools for patient-specific functional hip planning and postoperative analysis. OPSInsight and OPSReView have separate FDA decisions, alongside earlier OPS planning and femoral applications. ^[11][28][29]

FDA-cleared

Listed in Corin’s U.S. product catalog; availability and configurations vary by market.

Commercial development

Corin’s U.S. catalog combines established hip and knee implants with its Apollo guidance platform. Icona is described by the manufacturer as a limited market release. These portfolio listings do not establish nationwide availability or every proposed clinical application. ^[2][15]

Known Distribution Partners

1 partner

Publicly documented relationships; coverage may be incomplete.

Partner	Territory / scope	Products
MMG Medical Sales & Services (distributor-reported) ^{[17][18][19][20]}	U.S.-based distributor; Corin-specific territory not publicly specified	Revival revision hip; TriFit CF and TriFit TS stems; Icona stem; Trinity acetabular system and Trinity Dual Mobility

Sources checked October 22, 2026.

207 Cited Sources

Accessed 10/22/2026

Last substantive review: 10/22/2026

[1] Corin revival — official information ↗Corin Group · company website

[2] Corin icona — official information ↗Corin Group · company website

[3] Corin trinity — official information ↗Corin Group · company website

[4] Corin unity — official information ↗Corin Group · company website

[5] Corin apex — official information ↗Corin Group · company website

[6] FDA labeling and summary — K201657 ↗U.S. FDA · regulatory summary

[7] FDA labeling and summary — K261576 ↗U.S. FDA · regulatory summary

[8] FDA labeling and summary — K261275 ↗U.S. FDA · regulatory summary

[9] Corin apollo knee — official information ↗Corin Group · company website

[10] Corin apollo hip — official information ↗Corin Group · company website

[11] Corin ops — official information ↗Corin Group · company website

[12] Corin careers — official information ↗Corin Group · company website

[13] Corin contacts — official information ↗Corin Group · company website

[14] Corin founding — official information ↗Corin Group · company website

[15] Corin us catalog — official information ↗Corin Group · company website

[16] Corin Group — company size and headquarters ↗Corin Group / LinkedIn · company profile

[17] MMG Medical — implants listing (distributor-reported) ↗MMG Medical Sales & Services · distributor website

[18] MMG Medical — hip listing (distributor-reported) ↗MMG Medical Sales & Services · distributor website

[19] MMG Medical — revision listing (distributor-reported) ↗MMG Medical Sales & Services · distributor website

[20] MMG Medical — company listing (distributor-reported) ↗MMG Medical Sales & Services · company profile

[21] FDA 510(k) K153725 — Corin TaperFit Hip Stem ↗U.S. FDA · regulatory database · Published 2016-03-25

[22] FDA 510(k) K261576 — Icona Hip Stem ↗U.S. FDA · regulatory database · Published 2026-08-10

[23] FDA 510(k) K963046 — ENDOCAM ↗U.S. FDA · regulatory database · Published 1996-11-01

[24] FDA 510(k) K000634 — ROD TO ROD CROSS BRACES ↗U.S. FDA · regulatory database · Published 2000-03-10

[25] FDA 510(k) K022798 — CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS ↗U.S. FDA · regulatory database · Published 2002-11-19

[26] FDA 510(k) K153381 — Corin Metafix Hip Stem ↗U.S. FDA · regulatory database · Published 2016-01-21

[27] FDA 510(k) K240875 — Unity Knee PS-C Tibial Insert ↗U.S. FDA · regulatory database · Published 2024-06-26

[28] FDA 510(k) K193042 — Optimized Positioning System (OPS) ReView ↗U.S. FDA · regulatory database · Published 2020-06-26

[29] FDA 510(k) K192656 — Optimized Positioning System (OPS) Insight ↗U.S. FDA · regulatory database · Published 2020-05-01

[30] FDA 510(k) K241472 — Icona Hip Stem ↗U.S. FDA · regulatory database · Published 2024-10-03

[31] FDA 510(k) K965019 — THE C-FIT FEMORAL HIP SYSTEM ↗U.S. FDA · regulatory database · Published 1997-03-25

[32] FDA 510(k) K142761 — Corin TaperFit Hip Stem ↗U.S. FDA · regulatory database · Published 2015-04-03

[33] FDA 510(k) K152903 — REVIVAL(TM) Modular Revision Hip Stem ↗U.S. FDA · regulatory database · Published 2016-04-29

[34] FDA 510(k) K050764 — UNIGLIDE UNICONDYLAR KNEE PROSTHESIS ↗U.S. FDA · regulatory database · Published 2005-08-24

[35] FDA 510(k) K994152 — THE LIGAMENT ANCHOR SOFT SCREW ↗U.S. FDA · regulatory database · Published 2000-03-06

[36] FDA 510(k) K190143 — LARS AC Band Device ↗U.S. FDA · regulatory database · Published 2019-11-04

[37] FDA 510(k) K931753 — CORIN THOMPSON PROSTHESIS, MODIFICATION ↗U.S. FDA · regulatory database · Published 1994-10-07

[38] FDA 510(k) K193545 — Corin Optimized Positioning System (OPS) Femoral ↗U.S. FDA · regulatory database · Published 2020-08-04

[39] FDA 510(k) K120362 — METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY ↗U.S. FDA · regulatory database · Published 2012-05-04

[40] FDA 510(k) K973595 — THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM ↗U.S. FDA · regulatory database · Published 1997-12-19

[41] FDA 510(k) K000232 — ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS ↗U.S. FDA · regulatory database · Published 2000-02-25

[42] FDA 510(k) K083312 — MINIHIP STEM ↗U.S. FDA · regulatory database · Published 2010-04-05

[43] FDA 510(k) K003666 — TAPER-FIT TOTAL HIP SYSTEM ↗U.S. FDA · regulatory database · Published 2001-02-08

[44] FDA 510(k) K103518 — TRINITY ACETABULAR SYSTEM ↗U.S. FDA · regulatory database · Published 2011-03-09

[45] FDA 510(k) K190834 — Corin Optimized Position System Functional Hip Analysis (OPS FHA) ↗U.S. FDA · regulatory database · Published 2019-07-22

[46] FDA 510(k) K110087 — CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS ↗U.S. FDA · regulatory database · Published 2011-05-03

[47] FDA 510(k) K093472 — TRINITY ACETABULAR SYSTEM ↗U.S. FDA · regulatory database · Published 2010-11-23

[48] FDA 510(k) K931752 — CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION ↗U.S. FDA · regulatory database · Published 1994-10-07

[49] FDA 510(k) K990657 — TRIFIX PEDICLE SPINAL SCREW ASSEMBLY ↗U.S. FDA · regulatory database · Published 1999-03-26

[50] FDA 510(k) K173884 — Unity Total Knee System ↗U.S. FDA · regulatory database · Published 2018-01-17

[51] FDA 510(k) K082525 — CORIN METAFIX FEMORAL STEM ↗U.S. FDA · regulatory database · Published 2010-02-04

[52] FDA 510(k) K130343 — CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS ↗U.S. FDA · regulatory database · Published 2013-05-28

[53] FDA 510(k) K063791 — CORIN UNIPOLAR MODULAR HEAD ↗U.S. FDA · regulatory database · Published 2007-04-03

[54] FDA 510(k) K973005 — THE CORIFIX LIGAMENT ANCHOR ↗U.S. FDA · regulatory database · Published 1997-11-10

[55] FDA 510(k) K131986 — CORIN MINIHIP STEM ↗U.S. FDA · regulatory database · Published 2013-12-16

[56] FDA 510(k) K980545 — THE NUFFIELD TOTAL KNEE SYSTEM ↗U.S. FDA · regulatory database · Published 1998-04-29

[57] FDA 510(k) K131952 — CORIN METAFIX HIP STEM ↗U.S. FDA · regulatory database · Published 2013-12-16

[58] FDA 510(k) K992235 — ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS ↗U.S. FDA · regulatory database · Published 1999-11-23

[59] FDA 510(k) K973231 — THE CORIFIX DYNAMIC HIP SCREW SYSTEM ↗U.S. FDA · regulatory database · Published 1997-11-20

[60] FDA 510(k) K123705 — TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS ↗U.S. FDA · regulatory database · Published 2013-02-12

[61] FDA 510(k) K170359 — Trinity Dual Mobility System ↗U.S. FDA · regulatory database · Published 2017-10-31

[62] FDA 510(k) K203751 — OMNIVision system ↗U.S. FDA · regulatory database · Published 2021-04-12

[63] FDA 510(k) K183038 — Corin Optimized Positioning System (OPS) Plan ↗U.S. FDA · regulatory database · Published 2018-11-26

[64] FDA 510(k) K162942 — Corin MetaFix Hip Stem ↗U.S. FDA · regulatory database · Published 2017-06-20

[65] FDA 510(k) K010776 — TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS ↗U.S. FDA · regulatory database · Published 2001-04-06

[66] FDA 510(k) K111481 — CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS ↗U.S. FDA · regulatory database · Published 2012-02-06

[67] FDA 510(k) K212069 — Corin MetaFix Hip Stem ↗U.S. FDA · regulatory database · Published 2022-04-07

[68] FDA 510(k) K963043 — ENDOSPOT ↗U.S. FDA · regulatory database · Published 1996-09-20

[69] FDA 510(k) K183533 — Unity Total Knee System ↗U.S. FDA · regulatory database · Published 2019-06-04

[70] FDA 510(k) K972995 — THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM ↗U.S. FDA · regulatory database · Published 1997-11-10

[71] FDA 510(k) K172551 — Trinity PLUS Acetabular Shell ↗U.S. FDA · regulatory database · Published 2018-06-15

[72] FDA 510(k) K170808 — Unity Total Knee System ↗U.S. FDA · regulatory database · Published 2017-07-13

[73] FDA 510(k) K092198 — CORMET CEMENTLESS RESURFACING FEMORAL HEAD ↗U.S. FDA · regulatory database · Published 2010-04-15

[74] FDA 510(k) K992234 — THE TAPER-FIT TOTAL HIP SYSTEM ↗U.S. FDA · regulatory database · Published 1999-11-10

[75] FDA 510(k) K152893 — Corin Optimized Positioning System (OPS) ↗U.S. FDA · regulatory database · Published 2016-06-03

[76] FDA 510(k) K191831 — MobiliT Cup ↗U.S. FDA · regulatory database · Published 2020-01-16

[77] FDA 510(k) K181061 — Corin Optimized Positioning System (OPS) Femoral ↗U.S. FDA · regulatory database · Published 2018-09-07

[78] FDA 510(k) K111046 — CORIN MINIHIP FEMORAL STEM ↗U.S. FDA · regulatory database · Published 2011-06-29

[79] FDA 510(k) K122305 — CORIN TRINITY-I ACETABULAR SHELL ↗U.S. FDA · regulatory database · Published 2012-11-21

[80] FDA 510(k) K111911 — CORIN OPTIMOM MODULAR HEAD ↗U.S. FDA · regulatory database · Published 2011-08-04

[81] FDA 510(k) K925866 — CENATOR TOTAL HIP SYSTEM ↗U.S. FDA · regulatory database · Published 1993-09-23

[82] FDA 510(k) K131647 — TRINITY ACETABULAR SYSTEM ↗U.S. FDA · regulatory database · Published 2013-09-27

[83] FDA 510(k) K934166 — NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION ↗U.S. FDA · regulatory database · Published 1994-09-07

[84] FDA 510(k) K130128 — TRINITY ACETABULAR SYSTEM ↗U.S. FDA · regulatory database · Published 2013-03-08

[85] FDA 510(k) K191374 — Revival Modular Hip Stem ↗U.S. FDA · regulatory database · Published 2019-07-22

[86] FDA 510(k) K202805 — Optimized Positioning System (OPS) Insight ↗U.S. FDA · regulatory database · Published 2020-11-20

[87] FDA 510(k) K201657 — Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads ↗U.S. FDA · regulatory database · Published 2021-07-28

[88] FDA 510(k) K241570 — Unity Total Knee System ↗U.S. FDA · regulatory database · Published 2024-09-23

[89] FDA 510(k) K183114 — Corin BiPolar-i ↗U.S. FDA · regulatory database · Published 2019-06-05

[90] FDA 510(k) K113060 — UNITY TOATAL KNEE SYSTEM ↗U.S. FDA · regulatory database · Published 2012-09-10

[91] FDA 510(k) K103120 — CORIN BIOLOX DELTA FEMORAL HEADS ↗U.S. FDA · regulatory database · Published 2011-02-28

[92] FDA 510(k) K925897 — CORIN BIPOLAR PROSTHESIS ↗U.S. FDA · regulatory database · Published 1993-08-09

[93] FDA 510(k) K171847 — Corin Optimized Positioning System (OPS) Plan ↗U.S. FDA · regulatory database · Published 2018-04-05

[94] FDA 510(k) K121563 — CORIN TRIFIT TS HIP ↗U.S. FDA · regulatory database · Published 2012-10-05

[95] FDA 510(k) K010243 — TRI-FIT FEMORAL STEM ↗U.S. FDA · regulatory database · Published 2001-02-15

[96] FDA 510(k) K173880 — Corin TriFit CF Hip Stem ↗U.S. FDA · regulatory database · Published 2018-04-11

[97] FDA 510(k) K200888 — OMNIBotics Knee System ↗U.S. FDA · regulatory database · Published 2020-06-27

[98] FDA 510(k) K242744 — Trinity EVO Acetabular Shell ↗U.S. FDA · regulatory database · Published 2025-06-05

[99] FDA 510(k) K130634 — CORIN METAFIX HIP STEM ↗U.S. FDA · regulatory database · Published 2013-05-24

[100] FDA 510(k) K121439 — METAFIX FEMORAL HIP STEM SIZE 1 ↗U.S. FDA · regulatory database · Published 2012-09-14

[101] FDA 510(k) K973425 — THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM ↗U.S. FDA · regulatory database · Published 1998-02-27

[102] FDA 510(k) K231172 — ApolloKnee ↗U.S. FDA · regulatory database · Published 2023-07-26

[103] FDA 510(k) K241808 — ApolloHipX (THR.SS.0001) ↗U.S. FDA · regulatory database · Published 2025-01-07

[104] FDA 510(k) K012377 — OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES ↗U.S. FDA · regulatory database · Published 2002-03-11

[105] FDA 510(k) K153772 — Corin TriFit TS Hip ↗U.S. FDA · regulatory database · Published 2016-03-31

[106] FDA 510(k) K261275 — Unity Total Knee System, Unity Knee Cementless CR Femur ↗U.S. FDA · regulatory database · Published 2026-09-17

[107] FDA 510(k) K963044 — ENDOBEAM ↗U.S. FDA · regulatory database · Published 1996-09-20

[108] FDA 510(k) K994153 — CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS ↗U.S. FDA · regulatory database · Published 2000-02-25

[109] FDA 510(k) K082468 — APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) ↗U.S. FDA · regulatory database · Published 2009-02-18

[110] FDA 510(k) K060192 — APEX KNEE SYSTEM ↗U.S. FDA · regulatory database · Published 2006-06-15

[111] FDA 510(k) K110947 — APEX K1 HIP STEM ↗U.S. FDA · regulatory database · Published 2011-06-16

[112] FDA 510(k) K191765 — OMNI TiN Coated Apex Knee System ↗U.S. FDA · regulatory database · Published 2019-09-25

[113] FDA 510(k) K111193 — APEX ARC HIP STEM ↗U.S. FDA · regulatory database · Published 2011-06-27

[114] FDA 510(k) K090845 — APEX ARC HIP STEM ↗U.S. FDA · regulatory database · Published 2010-04-07

[115] FDA 510(k) K152919 — OMNI Skirted Heads ↗U.S. FDA · regulatory database · Published 2016-03-10

[116] FDA 510(k) K111062 — APEX KNEE SYSTEM, APEX ALL POLY TIBIA ↗U.S. FDA · regulatory database · Published 2011-07-13

[117] FDA 510(k) K101976 — INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET ↗U.S. FDA · regulatory database · Published 2010-09-14

[118] FDA 510(k) K060072 — MONOBLOCK PRESS-FIT HIP STEM ↗U.S. FDA · regulatory database · Published 2006-08-24

[119] FDA 510(k) K113242 — APEX ARC HIP STEM ↗U.S. FDA · regulatory database · Published 2012-01-05

[120] FDA 510(k) K100555 — APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK ↗U.S. FDA · regulatory database · Published 2010-03-29

[121] FDA 510(k) K080842 — APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] ↗U.S. FDA · regulatory database · Published 2008-05-23

[122] FDA 510(k) K073150 — APEX-LNK POLY ACETABULAR CUP LINERS ↗U.S. FDA · regulatory database · Published 2008-02-27

[123] FDA 510(k) K101451 — APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD ↗U.S. FDA · regulatory database · Published 2010-06-22

[124] FDA 510(k) K092443 — INTERFACE ACETABULAR CUP LINERS ↗U.S. FDA · regulatory database · Published 2009-10-23

[125] FDA 510(k) K131472 — APEX KNEE MODULAR TIBIA SYSTEM ↗U.S. FDA · regulatory database · Published 2013-10-08

[126] FDA 510(k) K112891 — APEX REVISION KNEE SYSTEMS ↗U.S. FDA · regulatory database · Published 2012-02-29

[127] FDA 510(k) K102578 — APEX PS KNEE SYSTEM ↗U.S. FDA · regulatory database · Published 2011-03-25

[128] FDA 510(k) K111184 — APEX PS KNEE SYSTEM - PS-C INSERT ↗U.S. FDA · regulatory database · Published 2011-06-22

[129] FDA 510(k) K094017 — TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 ↗U.S. FDA · regulatory database · Published 2010-03-05

[130] FDA 510(k) K163338 — OMNIBotics Knee System ↗U.S. FDA · regulatory database · Published 2017-09-01

[131] FDA labeling and summary — K191374 ↗U.S. FDA · regulatory summary

[132] FDA labeling and summary — K231172 ↗U.S. FDA · regulatory summary

[133] FDA labeling and summary — K241808 ↗U.S. FDA · regulatory summary

[134] FDA recall Z-0213-2024 — Unity CR Femur Right, Size 6, Model Number 112.001.32 ↗U.S. FDA · regulatory database · Published 2023-11-02

[135] FDA recall Z-0214-2024 — Unity Total Knee System, Model Number 112.001.34. ↗U.S. FDA · regulatory database · Published 2023-11-02

[136] FDA recall Z-0273-2023 — Unity Total Knee System. ↗U.S. FDA · regulatory database · Published 2022-11-21

[137] FDA recall Z-0726-2023 — Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 ↗U.S. FDA · regulatory database · Published 2022-12-19

[138] FDA recall Z-0727-2023 — Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 ↗U.S. FDA · regulatory database · Published 2022-12-19

[139] FDA recall Z-1290-2021 — Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extr ↗U.S. FDA · regulatory database

[140] FDA recall Z-1291-2021 — Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra ↗U.S. FDA · regulatory database

[141] FDA recall Z-1509-2022 — Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 5 ↗U.S. FDA · regulatory database

[142] FDA recall Z-1526-2016 — Trinity Acetabular System ↗U.S. FDA · regulatory database

[143] FDA recall Z-1527-2016 — Trinity Acetabular Shell ↗U.S. FDA · regulatory database

[144] FDA recall Z-1528-2016 — Trinity Acetabular Shell ↗U.S. FDA · regulatory database

[145] FDA recall Z-1667-2022 — TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.380 ↗U.S. FDA · regulatory database

[146] FDA recall Z-1850-2021 — Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component. ↗U.S. FDA · regulatory database

[147] FDA recall Z-1851-2021 — Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip pros ↗U.S. FDA · regulatory database

[148] FDA recall Z-2069-2025 — Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-5013 ↗U.S. FDA · regulatory database · Published 2025-07-02

[149] FDA recall Z-2603-2021 — Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile. ↗U.S. FDA · regulatory database

[150] FDA recall Z-2604-2021 — Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Co ↗U.S. FDA · regulatory database

[151] FDA recall Z-2605-2021 — Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, ↗U.S. FDA · regulatory database

[152] FDA recall Z-2606-2021 — Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and ↗U.S. FDA · regulatory database

[153] FDA recall Z-2607-2021 — Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a compone ↗U.S. FDA · regulatory database

[154] FDA recall Z-2608-2021 — Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Du ↗U.S. FDA · regulatory database

[155] FDA recall Z-2609-2021 — Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile. ↗U.S. FDA · regulatory database

[156] FDA recall Z-2610-2021 — Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Steri ↗U.S. FDA · regulatory database

[157] FDA recall Z-2611-2021 — Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile ↗U.S. FDA · regulatory database

[158] FDA recall Z-2612-2021 — Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a com ↗U.S. FDA · regulatory database

[159] FDA recall Z-0169-2020 — OMNI Hip System ↗U.S. FDA · regulatory database

[160] FDA recall Z-0237-2022 — OMNI K2 Hip Stem, Manufacturer's Product Code 130006 ↗U.S. FDA · regulatory database

[161] FDA recall Z-0610-2017 — OMNIBotics Tracker Kit -Model: RM-10000 ↗U.S. FDA · regulatory database · Published 2016-11-17

[162] FDA recall Z-0837-2019 — OMNI K1 Broach Handle, Product Code HS-10054 ↗U.S. FDA · regulatory database

[163] FDA recall Z-0920-2021 — SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modul ↗U.S. FDA · regulatory database

[164] FDA recall Z-0921-2021 — SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modul ↗U.S. FDA · regulatory database

[165] FDA recall Z-0922-2021 — SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modula ↗U.S. FDA · regulatory database

[166] FDA recall Z-1117-2018 — Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L ↗U.S. FDA · regulatory database

[167] FDA recall Z-1717-2019 — OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a ↗U.S. FDA · regulatory database

[168] FDA recall Z-1966-2009 — Apex Hip System Bipolar Head, 22.225mm ID, 38 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[169] FDA recall Z-1967-2009 — Apex Hip System Bipolar Head, 22.225mm ID, 39 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[170] FDA recall Z-1968-2009 — Apex Hip System Bipolar Head, 22.225mm ID, 40 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[171] FDA recall Z-1969-2009 — Apex Hip System Bipolar Head, 22.225mm ID, 41 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[172] FDA recall Z-1970-2009 — Apex Hip System Bipolar Head, 22.225mm ID, 42 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[173] FDA recall Z-1971-2009 — Apex Hip System Bipolar Head, 22.225mm ID, 43 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[174] FDA recall Z-1972-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[175] FDA recall Z-1973-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 45 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[176] FDA recall Z-1974-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 46 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[177] FDA recall Z-1975-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 47 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[178] FDA recall Z-1976-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 48 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[179] FDA recall Z-1977-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 49 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[180] FDA recall Z-1978-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 50 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[181] FDA recall Z-1979-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 51 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[182] FDA recall Z-1980-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 52 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[183] FDA recall Z-1981-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 53 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[184] FDA recall Z-1982-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 54 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[185] FDA recall Z-1983-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 55 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[186] FDA recall Z-1984-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 56 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[187] FDA recall Z-1985-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 57 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[188] FDA recall Z-1986-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 58 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[189] FDA recall Z-1987-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 59 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[190] FDA recall Z-1988-2009 — Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 60 mm OD ↗U.S. FDA · regulatory database · Published 2009-09-10

[191] FDA recall Z-2064-2015 — Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA ↗U.S. FDA · regulatory database · Published 2015-07-14

[192] FDA recall Z-2241-2014 — Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA ↗U.S. FDA · regulatory database · Published 2014-08-15

[193] FDA recall Z-2370-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm ↗U.S. FDA · regulatory database · Published 2012-09-13

[194] FDA recall Z-2371-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm ↗U.S. FDA · regulatory database · Published 2012-09-13

[195] FDA recall Z-2372-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm ↗U.S. FDA · regulatory database · Published 2012-09-13

[196] FDA recall Z-2373-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm ↗U.S. FDA · regulatory database · Published 2012-09-13

[197] FDA recall Z-2374-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm ↗U.S. FDA · regulatory database · Published 2012-09-13

[198] FDA recall Z-2375-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm ↗U.S. FDA · regulatory database · Published 2012-09-13

[199] FDA recall Z-2445-2015 — APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. ↗U.S. FDA · regulatory database · Published 2015-08-21

[200] FDA recall Z-2454-2015 — Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 ↗U.S. FDA · regulatory database · Published 2015-08-24

[201] FDA recall Z-2455-2015 — Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 ↗U.S. FDA · regulatory database · Published 2015-08-24

[202] FDA recall Z-2479-2019 — OMNIlife science, Inc. ↗U.S. FDA · regulatory database

[203] FDA recall Z-2480-2019 — OMNIlife science, Inc. ↗U.S. FDA · regulatory database

[204] FDA recall Z-2481-2019 — OMNIlife science, Inc. ↗U.S. FDA · regulatory database

[205] FDA recall Z-2540-2018 — OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-1392 ↗U.S. FDA · regulatory database

[206] FDA original PMA P050016 — historical Cormet hip resurfacing ↗U.S. FDA · regulatory database · Published 2007-07-03

[207] FDA De Novo database — Corin and OMNI named-requester searches ↗U.S. FDA · regulatory database

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