Data / Medical devices / United States / Ortho Solutions Inc
Ortho Solutions Inc: FDA-registered device maker in Nashville, TN, United States, 7 510(k) clearances
Ortho Solutions Inc is registered with the FDA (registration 3009812190) in Nashville, TN, United States. It lists 12 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 7, 2025. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009812190
- FEI number
- 3022270316
- Address
- 209 10th Avenue S Ste. 416, Nashville, TN, United States, 37203
- Owner or operator
- ORTHO SOLUTIONS INC (10042129)
- Roles
- Complaint file establishment
- First device listed
- October 23, 2012
- Registered through
- 2026
- Brand names listed
- ORTHO SOLUTIONS COGNiTiON STAPLE SYSTEM, ORTHO SOLUTIONS OXFORD ANKLE FUSION NAIL SYSTEM, ORTHO SOLUTIONS PLATING SYSTEM (Voliton Ankle Fracture), ORTHO SOLUTIONS STERILE DRILL BITS, Pins and Wires, Succession AFN System, Volition Plating System
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 7, 2025 | K250622 | Succession AFN System | HSB | Substantially Equivalent | Ortho Solutions UK , Ltd. | accessdata.fda.gov |
| February 23, 2024 | K240212 | COGNiTiON Staple System | JDR | Substantially Equivalent | Ortho Solutions UK , Ltd. | accessdata.fda.gov |
| April 13, 2021 | K210658 | Volition Plating System | HRS | Substantially Equivalent | Ortho Solutions UK , Ltd. | accessdata.fda.gov |
| November 20, 2020 | K202764 | Ortho Solutions Plating System | HRS | Substantially Equivalent | Ortho Solutions UK , Ltd. | accessdata.fda.gov |
| September 14, 2012 | K121575 | OXFORD ANKLE FUSION NAIL(AFN) SYSTEM | HSB | Substantially Equivalent | Ortho Solutions Limited | accessdata.fda.gov |
| December 19, 2011 | K110895 | ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS | HWC | Substantially Equivalent | Ortho Solutions Limited | accessdata.fda.gov |
| January 20, 2011 | K102743 | ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES | HWE | Substantially Equivalent | Ortho Solutions Limited | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 19, 2017 | 77490 | Class II | Terminated | 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. | accessdata.fda.gov |
| July 21, 2016 | 74849 | Class II | Terminated | 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. | accessdata.fda.gov |
| July 14, 2015 | 71899 | Class II | Terminated | 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 | accessdata.fda.gov |
Compare with other makers
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Screw, Fixation, Bone
- All makers of Washer, Bolt Nut
- All makers of Plate, Fixation, Bone
- All makers of Cerclage, Fixation
- All makers of Pin, Fixation, Threaded
Updated August 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.