Ortho Solutions Inc

Maldon Essex, GB

Ortho Solutions Inc appears in FDA device records in Maldon Essex, GB. FDA records list 11 510(k) clearances between 2011-01-20 and 2025-08-07, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 4 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 11
PMA records: 0
Recall records: 4
Registered establishments: 2

FDA records under these names

1 name

FDA records resolved to Ortho Solutions Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Ortho Solutions UK Limitedregistration, 510(k)

510(k) clearance history

FDA records hold 11 510(k) clearances for Ortho Solutions Inc between 2011 and 2025. The busiest year on record is 2012, with 3. The most recent is 2025, with 1.

Clearances by year, as a table

510(k) clearance decisions for Ortho Solutions Inc, by decision year
Year	Clearances
2011	2
2012	3
2014	1
2017	1
2020	1
2021	1
2024	1
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K250622	Succession™ AFN System	HSB	Substantially Equivalent	2025-08-07
K240212	COGNiTiON™ Staple System	JDR	Substantially Equivalent	2024-02-23
K210658	Volition Plating System	HRS	Substantially Equivalent	2021-04-13
K202764	Ortho Solutions Plating System	HRS	Substantially Equivalent	2020-11-20
K163489	OrthoSolutions 'System26' Bone Screws	HWC	Substantially Equivalent	2017-03-08
K141784	ORTHO SOLUTIONS ULTOS PLATING SYSTEM	HRS	Substantially Equivalent	2014-07-23
K121575	OXFORD ANKLE FUSION NAIL(AFN) SYSTEM	HSB	Substantially Equivalent	2012-09-14
K120360	ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS	HRS	Substantially Equivalent	2012-05-29
K111678	ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS	HRS	Substantially Equivalent	2012-02-07
K110895	ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS	HWC	Substantially Equivalent	2011-12-19
K102743	ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES	HWE	Substantially Equivalent	2011-01-20

Registered establishments

FDA registered establishments for Ortho Solutions Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3009812190	3022270316	Ortho Solutions Inc	209 10th Avenue S, Nashville, TN 37203 US	2026	GFA GFF HRS HSB HSZ HTN HTY HWC HWE JDQ and 2 more, listed in full below
3008951116	3008951116	Ortho Solutions UK Limited	West Station Business Park, Maldon Essex CM9 6FF GB	2026	FSM GFA GFF HRS HSB HSZ HTN HTW HTY HWC and 7 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0967-2018	SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS; OS900055-NS; OS900056-NS; OS900058-NS; OS900059-NS; OS900057-NS.	Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market.	Class II	2017-10-10	Terminated
Z-2780-2017	Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.	There is a material mislabeling of the AFN End Cap.	Class II	2017-04-19	Terminated
Z-2835-2016	FPS 35mm x 3.5 mm non-locking screw	Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.	Class II	2016-07-21	Terminated
Z-0026-2016	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw	Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ	Class II	2015-07-14	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain