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Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee

by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

510(k) K222056

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK222056 Date26 Jan 2023ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2732-2024 FDA Class II initiated 5 Aug 2024

    A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.

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  • Withdrawn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
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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