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Companies / SurGenTec
Medical device company profile

SurGenTec

Privately held manufacturer of spine and orthopedic implants, graft materials and surgical instruments.

Private manufacturerOrthopedics & MusculoskeletalSpineCommercial stage
Headquarters🇺🇸Boca Raton, Florida, United States
Founded2016
Commercial statusCommercially availableCurrent marketed U.S. portfolio; licensed and internally developed products
EmployeesNot confirmed
Estimated revenueNot confirmed
Official websitewww.surgentec.com ↗

Company overview

SurGenTec is a privately held medical device company based in Boca Raton, Florida. Its company history dates its founding by Travis Greenhalgh to 2016. The current portfolio spans facet fixation, sacroiliac joint fusion, synthetic bone grafts, allografts, graft-delivery instruments and surgical access tools. Flagship families include ION, TiLink, OsteoFlo and GraftGun.

The company markets products to spine and orthopedic surgeons and works through distribution relationships. Recent activity includes cervical and lumbar facet fixation clearances and navigation-compatible instruments. In October 2026, it announced an exclusive license for Allevion Medical's Vantage lumbar decompression technology, now listed in SurGenTec's portfolio. That FDA clearance predates the license and remains attributed to Allevion; compatibility with another manufacturer's navigation platform is not itself evidence of a corporate partnership.

Evidence varies across products. Published HydroFiber research includes a rabbit fusion model, while a manufacturer GraftRasp white paper describes three clinical cases and company announcements describe ION-C clinical follow-up. These sources should not be combined into a broad claim of human clinical superiority. FDA-cleared uses remain device-specific. Public revenue, funding-round totals, audited customer counts and confirmed payer coverage were not established in this review.

[50][85][86][88][89][90][107][108]

Leadership

2 people
Travis GreenhalghFounder · Chief Executive Officer [85][108]
Matt MartaVice President · Sales [88]

Products & regulatory status How does MedTechIndex get this information?

Summary

The reviewed portfolio contains 510(k)-cleared devices and graft products with different regulatory bases. ION facet fixation records include FDA's unclassified device category, which is distinct from a recall hazard class. Allograft catalog listings do not automatically establish clearance, approval or exemption. Exact labeled uses and concurrent-device requirements govern each device. [75][85][89][5][4][103][95][3]

No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [48][42]

Regulatory snapshot How to read this snapshot

U.S. FDA
32
510(k) clearances
0
De Novo grants
0
PMA approvals
0
Recall events

Latest recorded source review: 2026-10-20.

Commercial portfolio snapshot

Documented commercial product families.

Bone graft delivery system

GraftGun ↗

Universal graft delivery platform for delivery into surgical sites and cages. [92]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Decortication and graft-delivery instruments

3D GraftRasp ↗

Instrument family for decortication and graft delivery; not counted as a separate graft material. [94]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Access and aspiration instruments

ALARA / B-MAN ↗

Access needle and bone marrow aspiration kit family; neuro-access and BMA variants have separate FDA decisions. [91]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Facet fixation implants

ION / ION-3D ↗

Facet screw platform; bone-integration marketing includes animal evidence and should not be treated as human outcomes. [99]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Cervical facet fixation

ION-C ↗

Temporary adjunct stabilization for posterior cervical fusion. K251714 limits use to revision anterior pseudoarthrosis at one or two contiguous levels C3-C7, bilaterally, with FDA-cleared anterior plate and interbody device at the same levels. [97]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Lumbar facet fixation

ION-L ↗

Lumbar fixation family with separately cleared navigated instruments. [98]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

View 9 additional documented product families
SI joint fusion implants

TiLink-L ↗

SI joint fusion family including separately cleared navigation instruments. [104]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

SI joint fusion implants and kits

TiLink-P / INSITE ↗

Posterior SI joint fusion family and surgery-ready kit offering; packaging variants do not automatically add authorizations. [103]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Synthetic bone graft

OsteoFlo NanoPutty ↗

Quadphasic synthetic bone graft family. [96]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Synthetic bone graft

OsteoFlo HydroPutty ↗

Hydrophilic synthetic bone graft family. [102]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Synthetic bone graft

OsteoFlo HydroFiber ↗

Fiber-containing synthetic bone void filler; FDA labeling and clinical evidence are distinct. Rabbit fusion results do not establish equivalent human outcomes. [101]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Cortical fiber allograft

Ossify ↗

Allograft family listed by the company. Supplier/tissue regulatory mapping remains incomplete; do not infer a 510(k) clearance from a portfolio listing. [95]

Marketed · regulatory scope varies

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Allograft products

ViMax / ViMax Fiber Matrix ↗

Viable fiber and fiber matrix offerings. Company historical timeline references an Aziyo relationship; current processor and regulatory pathway require confirmation. [106]

Marketed · regulatory scope varies

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Facet instrumentation

FacetCore ↗

Current catalog offering; detailed regulatory mapping remains incomplete. [93]

Marketed · regulatory scope varies

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Lumbar decompression kit

Vantage ↗

Sterile, single-use decompression instruments licensed from Allevion Medical. FDA K252546 predates the SurGenTec license; this is a license, not an acquisition. [105][88]

FDA-cleared

Listed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Commercial development

Current research and recent regulatory expansions are tracked in the timeline. Durashield has an FDA clearance but its commercial status was not confirmed, so it is excluded from the marketed scorecard; clearance alone does not establish a launch or an active commercial-development program. [100]

Activity & Milestones

8 events
2026-10-08 · Commercial partnership

Exclusive Vantage license announced

SurGenTec announced an exclusive technology license with Allevion Medical. Vantage is listed in its current portfolio; K252546 retains Allevion as original FDA applicant. [88]

2026-06-11 · Regulatory

ION-L clearance

FDA cleared K261209 for Ion-L; navigated instruments have a separate decision, K262121 dated July 24, 2026. [79]

2026-04-20 · Preclinical evidence

HydroFiber preclinical study published

A peer-reviewed rabbit posterolateral fusion study compared HydroFiber and autograft through 12 weeks. These preclinical findings are not a human noninferiority trial. [50]

2026-03-20 · Regulatory

TiLink-L navigation instruments cleared

FDA decision K253604. The company's April announcement describes StealthStation compatibility; compatibility alone is not proof of a corporate Medtronic partnership. [77]

2026-01-16 · Regulatory

ION-C clearance

FDA K251714 covers defined cervical revision pseudoarthrosis uses, with bilateral implantation and specified concurrent cleared devices. It is not unrestricted stand-alone cervical fixation. [74]

2020-05-18 · Regulatory

3D GraftRasp clearance

FDA cleared K200431; a later 2020 decision also appears in the family's authorization history. [55]

2017-07-19 · Regulatory

GraftGun clearance

FDA cleared K170675 for the Graftgun Universal Graft Delivery System. The company timeline separately reports market launch in 2017. [51]

2016 · Company history

Company founded

The company history timeline identifies 2016 as SurGenTec's founding by Travis Greenhalgh in Boca Raton. [108]

108 Cited Sources

Accessed 10/20/2026

[1] FDA 510(k) database — research search ↗U.S. FDA / openFDA · regulatory database
[2] FDA 510(k) database — research search ↗U.S. FDA / openFDA · regulatory database
[4] FDA K101525 — PIONEER SPINOUS PROCESS FUSION PLATE ↗U.S. Food and Drug Administration · regulatory record
[5] FDA K110367 — PIONEER SPINAL PROCESS FUSION PLATE ↗U.S. Food and Drug Administration · regulatory record
[6] FDA K170675 — Graftgun Universal Graft Delivery System ↗U.S. Food and Drug Administration · regulatory record
[7] FDA K180937 — Graftgun Universal Graft Delivery System ↗U.S. Food and Drug Administration · regulatory record
[8] FDA K190163 — ALARA Neuro Access Kit ↗U.S. Food and Drug Administration · regulatory record
[9] FDA K200064 — OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft ↗U.S. Food and Drug Administration · regulatory record
[10] FDA K200431 — 3D GraftRasp System ↗U.S. Food and Drug Administration · regulatory record
[11] FDA K201900 — 3D GraftRasp System ↗U.S. Food and Drug Administration · regulatory record
[12] FDA K211855 — Ion Facet Screw System ↗U.S. Food and Drug Administration · regulatory record
[13] FDA K230446 — TiLink-L SI Joint Fusion System ↗U.S. Food and Drug Administration · regulatory record
[14] FDA K230857 — TiLink-P SI Joint Fusion System ↗U.S. Food and Drug Administration · regulatory record
[15] FDA K231716 — OsteoFlo® HydroPutty™ ↗U.S. Food and Drug Administration · regulatory record
[16] FDA K231831 — TiLink-L Joint Fusion System ↗U.S. Food and Drug Administration · regulatory record
[17] FDA K240086 — Ion 3D ↗U.S. Food and Drug Administration · regulatory record
[19] FDA K240720 — TiLink-P SI Joint Fusion System ↗U.S. Food and Drug Administration · regulatory record
[20] FDA K241416 — Ion 3D ↗U.S. Food and Drug Administration · regulatory record
[21] FDA K242141 — TiLink-P SI Joint Fusion System ↗U.S. Food and Drug Administration · regulatory record
[22] FDA K242414 — TiLink-P Joint Fusion System ↗U.S. Food and Drug Administration · regulatory record
[23] FDA K242797 — OsteoFlo HydroFiber ↗U.S. Food and Drug Administration · regulatory record
[24] FDA K243265 — Ion 3D ↗U.S. Food and Drug Administration · regulatory record
[25] FDA K243580 — GraftGun Universal Graft Delivery System (GDS) ↗U.S. Food and Drug Administration · regulatory record
[26] FDA K243835 — TiLink-P SI Joint Fusion System ↗U.S. Food and Drug Administration · regulatory record
[28] FDA K243949 — OsteoFlo HydroFiber ↗U.S. Food and Drug Administration · regulatory record
[29] FDA K251714 — Ion-C ↗U.S. Food and Drug Administration · regulatory record
[30] FDA K251720 — OsteoFlo HydroFiber ↗U.S. Food and Drug Administration · regulatory record
[31] FDA K252546 — VantageTM Lumbar Decompression Kit ↗U.S. Food and Drug Administration · regulatory record
[32] FDA K252995 — Durashield Device Kit ↗U.S. Food and Drug Administration · regulatory record
[33] FDA K253604 — TiLink-L Navigation Instruments ↗U.S. Food and Drug Administration · regulatory record
[34] FDA K260329 — Ion-C Navigation Instruments ↗U.S. Food and Drug Administration · regulatory record
[35] FDA K261209 — Ion-L ↗U.S. Food and Drug Administration · regulatory record
[36] FDA K261381 — TiLink-L™ SI Joint Fusion System ↗U.S. Food and Drug Administration · regulatory record
[37] FDA K262121 — Ion-L Navigated Instruments ↗U.S. Food and Drug Administration · regulatory record
[43] FDA PMA database — research search ↗U.S. FDA / openFDA · regulatory database
[44] FDA PMA database — research search ↗U.S. FDA / openFDA · regulatory database
[50] OsteoFlo HydroFiber — rabbit posterolateral fusion study ↗Blom et al. / Global Spine Journal · peer reviewed preclinical research · Published 2026-04-20
[51] K170675 — Graftgun Universal Graft Delivery System ↗U.S. FDA · regulatory decision · Published 2017-07-19
[52] K180937 — Graftgun Universal Graft Delivery System ↗U.S. FDA · regulatory decision · Published 2018-05-10
[53] K190163 — ALARA Neuro Access Kit ↗U.S. FDA · regulatory decision · Published 2019-07-16
[54] K200064 — OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft ↗U.S. FDA · regulatory decision · Published 2020-08-14
[55] K200431 — 3D GraftRasp System ↗U.S. FDA · regulatory decision · Published 2020-05-18
[56] K201900 — 3D GraftRasp System ↗U.S. FDA · regulatory decision · Published 2020-09-03
[57] K211855 — Ion Facet Screw System ↗U.S. FDA · regulatory decision · Published 2022-02-25
[58] K230446 — TiLink-L SI Joint Fusion System ↗U.S. FDA · regulatory decision · Published 2023-06-07
[59] K230857 — TiLink-P SI Joint Fusion System ↗U.S. FDA · regulatory decision · Published 2023-09-25
[60] K231716 — OsteoFlo HydroPutty™ ↗U.S. FDA · regulatory decision · Published 2023-10-02
[61] K231831 — TiLink-L Joint Fusion System ↗U.S. FDA · regulatory decision · Published 2023-08-03
[62] K240086 — Ion 3D ↗U.S. FDA · regulatory decision · Published 2024-02-08
[64] K240720 — TiLink-P SI Joint Fusion System ↗U.S. FDA · regulatory decision · Published 2024-04-11
[65] K241416 — Ion 3D ↗U.S. FDA · regulatory decision · Published 2024-06-17
[66] K242141 — TiLink-P SI Joint Fusion System ↗U.S. FDA · regulatory decision · Published 2024-08-21
[67] K242414 — TiLink-P Joint Fusion System ↗U.S. FDA · regulatory decision · Published 2024-11-21
[68] K242797 — OsteoFlo HydroFiber ↗U.S. FDA · regulatory decision · Published 2024-12-23
[69] K243265 — Ion 3D ↗U.S. FDA · regulatory decision · Published 2024-12-04
[70] K243580 — GraftGun Universal Graft Delivery System (GDS) ↗U.S. FDA · regulatory decision · Published 2025-02-05
[71] K243835 — TiLink-P SI Joint Fusion System ↗U.S. FDA · regulatory decision · Published 2024-12-27
[73] K243949 — OsteoFlo HydroFiber ↗U.S. FDA · regulatory decision · Published 2025-05-28
[74] K251714 — Ion-C ↗U.S. FDA · regulatory decision · Published 2026-01-16
[75] K252546 — Vantage Lumbar Decompression Kit ↗U.S. FDA · regulatory decision · Published 2026-03-12
[76] K252995 — Durashield Device Kit ↗U.S. FDA · regulatory decision · Published 2026-09-17
[77] K253604 — TiLink-L Navigation Instruments ↗U.S. FDA · regulatory decision · Published 2026-03-20
[78] K260329 — Ion-C Navigation Instruments ↗U.S. FDA · regulatory decision · Published 2026-05-22
[79] K261209 — Ion-L ↗U.S. FDA · regulatory decision · Published 2026-06-11
[80] K261381 — TiLink-L™ SI Joint Fusion System ↗U.S. FDA · regulatory decision · Published 2026-08-24
[81] K262121 — Ion-L Navigated Instruments ↗U.S. FDA · regulatory decision · Published 2026-07-24
[82] K262581 — GraftGun Universal Graft Delivery System (GDS) ↗U.S. FDA · regulatory decision · Published 2026-08-26
[84] K251720 — OsteoFlo HydroFiber ↗U.S. FDA · regulatory decision · Published 2025-07-02
[85] ION-C clearance and commercial availability announcement ↗SurGenTec via Business Wire · company announcement · Published 2026-01-19
[86] TiLink navigation commercialization announcement ↗SurGenTec via Business Wire · company announcement · Published 2026-04-15
[87] ION-L navigation announcement ↗SurGenTec via Business Wire · company announcement
[88] Exclusive Vantage license with Allevion Medical ↗SurGenTec via Business Wire · company announcement · Published 2026-10-08
[90] Company background and history ↗SurGenTec · company website
[92] GraftGun — product page ↗SurGenTec · company website
[93] FacetCore — product page ↗SurGenTec · company website
[95] Ossify — product page ↗SurGenTec · company website
[97] ION-C — product page ↗SurGenTec · company website
[98] ION-L — product page ↗SurGenTec · company website
[100] Company news index ↗SurGenTec · company website
[104] TiLink-L — product page ↗SurGenTec · company website
[105] Vantage — product page ↗SurGenTec · company website
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