Skip to the page
Get started free

Data / Medical devices / United Kingdom / Ortho Solutions UK Limited

Ortho Solutions UK Limited: FDA-registered device maker in Maldon Essex, United Kingdom, 10 510(k) clearances

Ortho Solutions UK Limited is registered with the FDA (registration 3008951116) in Maldon Essex, United Kingdom. It lists 17 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 7, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Ortho Solutions UK Limited
FDA registration number
3008951116
Address
West Station Business Park Spital Road, Maldon Essex, United Kingdom, CM9 6FF
Owner or operator
Ortho Solutions UK Ltd (10035321)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
February 19, 2011
Registered through
2026
Brand names listed
ACL/PCL Passing Pins, Bone Plate/Screw/Washer - Large Fragment (LFS), Bone Plate/Screw/Washer - Mini Fragment (MFS), Bone Plate/Screw/Washer - Small Fragment (SFS), Burr, CHS/SCS Compression Plate, Cannulated Bone Screw Systems, Cerclage Wire and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Manufactureraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Manufactureraccessdata.fda.gov
Cerclage, FixationJDQ2Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentKIJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentHSZ1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Manufactureraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Staple, Fixation, BoneJDR2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Specification developeraccessdata.fda.gov
Washer, Bolt NutHTN2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 7, 2025K250622Succession™ AFN SystemHSBSubstantially EquivalentOrtho Solutions UK , Ltd.accessdata.fda.gov
February 23, 2024K240212COGNiTiON™ Staple SystemJDRSubstantially EquivalentOrtho Solutions UK , Ltd.accessdata.fda.gov
April 13, 2021K210658Volition Plating SystemHRSSubstantially EquivalentOrtho Solutions UK , Ltd.accessdata.fda.gov
November 20, 2020K202764Ortho Solutions Plating SystemHRSSubstantially EquivalentOrtho Solutions UK , Ltd.accessdata.fda.gov
March 8, 2017K163489OrthoSolutions 'System26' Bone ScrewsHWCSubstantially EquivalentOrtho Solutions UK Limitedaccessdata.fda.gov
September 14, 2012K121575OXFORD ANKLE FUSION NAIL(AFN) SYSTEMHSBSubstantially EquivalentOrtho Solutions Limitedaccessdata.fda.gov
May 29, 2012K120360ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESISHRSSubstantially EquivalentOrtho Solutions Limitedaccessdata.fda.gov
February 7, 2012K111678ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESISHRSSubstantially EquivalentOrtho Solutions Limitedaccessdata.fda.gov
December 19, 2011K110895ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESISHWCSubstantially EquivalentOrtho Solutions Limitedaccessdata.fda.gov
January 20, 2011K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESHWESubstantially EquivalentOrtho Solutions Limitedaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
October 10, 201779218Class IITerminatedSYSTEM 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; 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.accessdata.fda.gov

Compare with other makers

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.