Modular Rotating Hinge Knee Systems and Compatible Components

by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

510(k) K223069

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

510(k) K223069↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK223069	Date21 Apr 2023Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K223069
FDA Product Code: KRO

Device Class: Class II
Regulation: 21 CFR Part 888.3510
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

Other devices from Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Triathlon® Knee System

Class II
Omnifit® 20° Series I Insert Open recall

Class II
Stryker Orthopaedics Hip Systems Labeling Update

Class II
UHR Bipolar Implants, Restoration GAP II Implants

Class II
Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components Open recall

Class II
Restoration Anatomic Shell

Class II

See all devices from Howmedica Osteonics Corp., Dba Stryker Orthopaedics →