ClearanceBrief
Panels › Orthopedic › Product code HSX · Class 2

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Regulation 888.3520

3510(k)s in 12 months (115 all time)
0recalls in 12 months (104 all time)
100recalls that name a 510(k)
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Top companies in HSX

Company510(k)sRecalls
Smith & Nephew, Inc.1354
Linkbio Corp.032
Conformis, Inc.83
Zimmer, Inc.92
Bodycad Laboratories, Inc.70
Mako Surgical Corp.60
Zimmer Biomet15
Depuy, Inc.50
Howmedica Corp.50
Medacta International S.A.50
Decided510(k)Device and applicantCode
Aug 4, 2026K261609Freedom Partial Knee System
Maxx Orthopedics, Inc.
HSX
Apr 2, 2026K260796Tahoe Unicondylar Knee System with TiNbN Overcoat
Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
HSX
Dec 16, 2025K251771Cambridge Partial Knee
Signature Orthopaedics Pty, Ltd., AU
HSX
Aug 15, 2025K251834Persona Partial Knee
Zimmer Biomet
HSX
Jul 24, 2025K251618MOTO Partial Knee System Extension
Medacta International S.A., CH
HSX
Jul 1, 2025K251453Arthrex iBalance Partial Knee System
Arthrex, Inc.
HSX
Dec 6, 2024K241260ACTIFY™ Unicondylar Knee System
Globus Medical, Inc.
HSX
Oct 30, 2024K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
Smith & Nephew, Inc.
HSX
Oct 7, 2024K242746OvertureTi Knee Resurfacing SystemTM
Overture Orthopaedics
HSX
Apr 4, 2024K232114TRIBRID® Unicompartmental Knee System
Kyocera Medical Technologies, Inc.
HSX
Mar 10, 2023K221292Uni Knee Resurfacing System
Overture Resurfacing, Inc.
HSX
Jun 16, 2022K212870TLC Unicompartmental Knee System
Signature Orthopaedics Pty, Ltd., AU
HSX
Jun 2, 2022K220930Restoris Multi-Compartmental Knee System
Mako Surgical Corp.
HSX
Dec 16, 2021K211471Balanced Knee System Uni
Ortho Development Corporation
HSX
Nov 16, 2021K213071MOTOTM Partial Knee & MOTO PFJ Systems Extension
Medacta International S.A., CH
HSX
Oct 12, 2021K212307BC Reflex Uni Knee System
Bodycad Laboratories, Inc., CA
HSX
Sep 16, 2021K211512VISIONAIRE UK Patient Matched Cutting Guides
Smith & Nephew, Inc.
HSX
Aug 20, 2021K211895BC Reflex Uni Knee System
Bodycad Laboratories, Inc., CA
HSX
Mar 12, 2021K203697BC Reflex Uni Knee System
Bodycad Laboratories, Inc., CA
HSX
Jan 8, 2021K203341ACS LD Uni FB Knee System
Implantcast GmbH, DE
HSX
Oct 27, 2020K203099Triathlon PKR System
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
HSX
Oct 2, 2020K202207Materialise PKA Guide System
Materialise NV, BE
HSX
Mar 17, 2020K200433iBalance UKA Tibial Tray Implant
Arthrex, Inc.
HSX
Mar 17, 2020K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right
Zimmer, Inc.
HSX
Dec 5, 2019K191996BC Reflex Uni Knee System
Bodycad Laboratories, Inc., CA
HSX
Oct 8, 2019K191150Bodycad Unicompartmental Knee System
Bodycad Laboratories, Inc., CA
HSX
Jul 25, 2019K191211JOURNEY II Unicompartmental Knee System
Smith & Nephew, Inc.
HSX
Jul 16, 2019K191325EMPOWR Partial Knee
Encore Medical L.P.
HSX
Feb 11, 2019K190085Journey II Unicompartmental Knee System
Smith & Nephew, Inc.
HSX
Jan 30, 2019K183029MOTO Partial Knee System
Medacta International S.A., CH
HSX
Jan 17, 2019K181302Bodycad Unicompartmental Knee System
Bodycad Laboratories, Inc., CA
HSX
Jul 6, 2018K173970Materialise PKA Guide System
Materialise NV, BE
HSX
Jun 7, 2018K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
HSX
Nov 20, 2017K172650Materialise PKA Guide System
Materialise NV, BE
HSX
Oct 5, 2017K170344Tahoe Uni Knee System
Consensus Orthopedics, Inc.
HSX
Apr 14, 2017K161741GMK UNI
Medacta International S.A., CH
HSX
Mar 29, 2017K163700Bodycad Unicompartmental Knee System
Bodycad Laboratories, Inc., CA
HSX
Jan 3, 2017K162084MOTO Partial Knee System
Medacta International S.A., CH
HSX
Dec 15, 2016K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing
Arthrex, Inc.
HSX
Nov 3, 2016K161592Persona Partial Knee System
Biomet, Inc.
HSX
Jun 15, 2016K160738ZUK Select Knee System
Smith & Nephew, Inc.
HSX
Oct 28, 2015K152315JOURNEY II Uni Tibial Base and Insert
Smith & Nephew, Inc.
HSX
Dec 5, 2013K132640IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
Conformis, Inc.
HSX
May 31, 2013K123380STRIDE UNICONDYLAR KNEE
Blue Belt Technologies, Inc.
HSX
Nov 16, 2012K122529ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
Zimmer, Inc.
HSX
Sep 6, 2012K121974CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
Conformis, Inc.
HSX
Jul 25, 2012K120262HLS UNI EVOLUTION & U-KNEETEC
Tornier, Inc., FR
HSX
Jan 6, 2012K112301ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
Materialise NV, BE
HSX
Jan 5, 2012K113038SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
Smith & Nephew, Inc.
HSX
Sep 29, 2011K111916CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
Conformis, Inc.
HSX

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