Device type
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Product code JWH · Class II · 21 CFR 888.3560 · Orthopedic
Recent 510(k)s
Oct 29, 2026
K263065
MicroPort Total Knee System
Suzhou Microport Orthorecon Co., Ltd.
- JWH
- Class II
Sep 15, 2026
K262057
GMK Extension
Medacta International SA
- JWH
- Class II
Sep 11, 2026
K260063
GSPE Spacer
The General Hospital Corporation, d/b/a Massachusetts
- JWH
- Class II
Sep 10, 2026
K262293
EVOLUTION MPX™ Total Knee System
Suzhou Microport Orthorecon Co., Ltd.
- JWH
- Class II
Sep 8, 2026
K262341
b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
B-One Ortho, Corp.
- JWH
- Class II
Sep 4, 2026
K262130
ATTUNE Revision Knee System
Depuy Orthopaedics, Inc.
- JWH
- Class II
Sep 1, 2026
K253961
SK Knee System
Just Medical Devices (Tianjin) Co., Ltd.
- JWH
- Class II
Recent recalls
Nov 3, 2026
Z-0356-2027
Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040.
CORIN MEDICAL, LTD.
- JWH
- Class II
- Open, Classified
Sep 23, 2026
Z-3197-2026
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME…
Howmedica Osteonics Corp.
- JWH
- Class II
- Ongoing