Ankle fusion nail system
SUCCESSION TTC Nail System ↗
Intramedullary nail system for hindfoot fusion, with instrumentation and independent compression features described in the current product materials. [19][11]
Commercial · U.S. 510(k)-clearedCompanies / OrthoSolutions
Medical device company profile
OrthoSolutions
UK orthopedic device company developing foot-and-ankle implants and instrumentation, with U.S. operations led by Kevin Brothen.
Medical Device Manufacturer and DeveloperOrthopedics & MusculoskeletalFoot & Ankle
Company overview
OrthoSolutions is a specialist orthopedic device business based in Maldon, Essex, with U.S. operations in Nashville, Tennessee. Founded in 2001, it develops implants and instrumentation for foot-and-ankle reconstruction and fixation.
Its portfolio includes SUCCESSION ankle-fusion nails, COGNiTiON staples, System 26 screws and Volition plating systems. The company also provides surgeon education and procedural support. Co-founders Eliot Clare and Rupert Hosking remain listed as owners, and Kevin Brothen is its U.S. president.
The business has its own device-development portfolio as well as regional distribution relationships. U.S. regulatory records should be matched to Ortho Solutions UK and its associated legal names; similarly named Response Ortho Solutions is a separate applicant. Historical recalls involved specific legacy products and batches rather than every current OrthoSolutions implant.
Leadership
6 peopleEliot ClareCo-founder & Owner [17]
Rupert HoskingCo-founder & Owner [17]
Kevin BrothenU.S. President [17]
Colin FisherFinance Director [17]
Dara AlmondCommercial Director [17]
Kevin StampDesign Director [17]
Products & regulatory status How does MedTechIndex get this information?
Summary
Selected FDA records include System 26 bone screws (K163489), COGNiTiON staples (K240212), Volition plating (K210658) and the SUCCESSION AFN system (K250622). Applicant-name matches for Response Ortho Solutions were excluded as a different company. [3][4][5][1][7][6][10][9][8][11][2]
Four historical Class II recalls were verified, all listed as terminated: UltOS 3.5 mm locking screws, FPS 35 mm × 3.5 mm screws, Oxford/Oxbridge AFN end caps and specified System 26 trays. The issues involved locking-thread specifications, labeling or corrosion residue in the affected devices. These records do not establish a recall of all currently sold implants. [3][4][5][1][7][6][10][9][8][11][2]
Regulatory snapshot How to read this snapshot
U.S. FDA- 3+
- 510(k) clearances
- —
- De Novo grants
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- PMA approvals
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- Recall events
Latest recorded source review: 2026-11-05.
Scope: selected product families.
Commercial portfolio snapshot
Documented commercial product families.
Bone fixation screws and instrumentation
System 26 Cannulated Screw System ↗
Headed and headless screw configurations with instrumentation for forefoot, midfoot and hindfoot fixation. A terminated 2017 recall concerned specified historical System 26 trays. [20][7]
Commercial · U.S. 510(k)-cleared
Bone fixation staple system
COGNiTiON Staple System ↗
Implant family with two-leg and four-leg staples for fixation in forefoot and hindfoot procedures. [18][10]
Commercial · U.S. 510(k)-clearedActivity & Milestones
3 events2025-08-07 · Regulatory
SUCCESSION AFN receives U.S. clearance
FDA cleared the nail system under K250622. [11]
2024-02-23 · Regulatory
COGNiTiON receives U.S. clearance
FDA cleared the staple system under K240212. [10]
20 Cited Sources
Accessed 11/05/2026
20 Cited Sources
Accessed 11/05/2026
[1] FDA 510(k) K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES ↗U.S. Food and Drug Administration · regulator · Published 2011-01-20
[2] FDA 510(k) K110895 — ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS ↗U.S. Food and Drug Administration · regulator · Published 2011-12-19
[3] FDA 510(k) K111678 — ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS ↗U.S. Food and Drug Administration · regulator · Published 2012-02-07
[4] FDA 510(k) K120360 — ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS ↗U.S. Food and Drug Administration · regulator · Published 2012-05-29
[5] FDA 510(k) K121575 — OXFORD ANKLE FUSION NAIL(AFN) SYSTEM ↗U.S. Food and Drug Administration · regulator · Published 2012-09-14
[6] FDA 510(k) K141784 — ORTHO SOLUTIONS ULTOS PLATING SYSTEM ↗U.S. Food and Drug Administration · regulator · Published 2014-07-23
[7] FDA 510(k) K163489 — OrthoSolutions 'System26' Bone Screws ↗U.S. Food and Drug Administration · regulator · Published 2017-03-08
[8] FDA 510(k) K202764 — Ortho Solutions Plating System ↗U.S. Food and Drug Administration · regulator · Published 2020-11-20
[9] FDA 510(k) K210658 — Volition Plating System ↗U.S. Food and Drug Administration · regulator · Published 2021-04-13
[10] FDA 510(k) K240212 — COGNiTiON™ Staple System ↗U.S. Food and Drug Administration · regulator · Published 2024-02-23
[11] FDA 510(k) K250622 — Succession™ AFN System ↗U.S. Food and Drug Administration · regulator · Published 2025-08-07
[12] FDA recall Z-0026-2016 — UltOS 3.5mm locking screw (12mm to 50mm) ↗U.S. Food and Drug Administration · regulator
[13] FDA recall Z-2835-2016 — FPS 35mm x 3.5 mm nonlocking screw ↗U.S. Food and Drug Administration · regulator
[14] FDA recall Z-2780-2017 — Oxford/Oxbridge AFN End Cap ↗U.S. Food and Drug Administration · regulator
[15] FDA recall Z-0967-2018 — System 26 Headed and Headless Bone Screw and Washer System ↗U.S. Food and Drug Administration · regulator
[16] OrthoSolutions Group — company size, founding year and headquarters ↗OrthoSolutions / LinkedIn · other
[17] OrthoSolutions — current leadership ↗OrthoSolutions · manufacturer
[18] COGNiTiON Staple System ↗OrthoSolutions · manufacturer
[19] SUCCESSION TTC Nail System ↗OrthoSolutions · manufacturer
[20] System 26 Cannulated Screw System ↗OrthoSolutions · manufacturer