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Ortho Solutions Extremity Fixation Implants for Osteosysnthesis

by Ortho Solutions Limited

510(k) K111678

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

Ortho Solutions Limited provides a comprehensive range of orthopedic implants for osteosynthesis, including hip replacements, knee replacements, and other extremity fixation solutions. Our implants are designed to ensure optimal stability and functionality for patients with joint pain or damage.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111678 Date7 Feb 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2835-2016 FDA Class II initiated 21 Jul 2016 on shared 510(k) K111678

    Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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