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Panels › Orthopedic › Product code NPJ · Class 2

Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Regulation 888.3560

0510(k)s in 12 months (12 all time)
1recalls in 12 months (9 all time)
8recalls that name a 510(k)
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Top companies in NPJ

Company510(k)sRecalls
Mako Surgical Corp.33
Conformis, Inc.23
Smith & Nephew, Inc.40
DePuy Orthopaedics, Inc.20
Howmedica Osteonics Corp.11
Stryker Howmedica Osteonics Corp.02
DateFirm and productCodeLinked 510(k)
Sep 16, 2026Howmedica Osteonics Corp.
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Open, Classified		 NPJK051948
K052917 +2
Jun 1, 2018Mako Surgical Corporation
Restoris MCK Onlay Insert Extractor.
Terminated		 NPJK090763
Jan 15, 2016Mako Surgical Corporation
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Terminated		 NPJK090763
Oct 21, 2015ConforMIS, Inc.
ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)
Terminated		 NPJK093513
K133256
Oct 21, 2015ConforMIS, Inc.
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
Terminated		 NPJK093513
K133256
Oct 21, 2015ConforMIS, Inc.
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
Terminated		 NPJK093513
K133256
Mar 4, 2014Mako Surgical Corporation
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system
Terminated		 NPJK090763
Jan 11, 2012Stryker Howmedica Osteonics Corp.
Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica International S. de R.L., Raheen Business Park, Limerick, Ireland. Intended for use in Unicompartmental Knee Arthroplasty
Terminated		 NPJK052917
Feb 24, 2005Stryker Howmedica Osteonics Corp.
The Triathlon Posteriorly Stabilized Femoral Component.
Terminated		 NPJNone listed

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