ClearanceBrief
Panels › Orthopedic › Product code KRR · Class 2

Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Regulation 888.3540

0510(k)s in 12 months (27 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
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Top companies in KRR

Company510(k)sRecalls
Howmedica Osteonics Corp.40
Arthrosurface, Inc.30
Biomet, Inc.21
MEDLINE INDUSTRIES, LP - Northfield03
Zimmer, Inc.12
Zimmer Biomet, Inc.03
Biomet Manufacturing Corp20
Mako Surgical Corp.20
Accelerated Innovation, LLC10
Arthrex, Inc.10
DateFirm and productCodeLinked 510(k)
Feb 1, 2023MEDLINE INDUSTRIES, LP - Northfield
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
Open, Classified		 KRRK181280
Feb 1, 2023MEDLINE INDUSTRIES, LP - Northfield
MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
Open, Classified		 KRRK181280
Feb 1, 2023MEDLINE INDUSTRIES, LP - Northfield
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
Open, Classified		 KRRK181280
Nov 29, 2017Zimmer Biomet, Inc.
ZIMMER PATELLA FEMORAL JOINT Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
Terminated		 KRRK070695
Nov 29, 2017Zimmer Biomet, Inc.
PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
Terminated		 KRRK070695
Apr 4, 2016Biomet, Inc.
All instrumentation associated with the Prelude PF Resurfacing Knee System.
Terminated		 KRRK123907
K143543
Feb 22, 2016Zimmer Biomet, Inc.
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthriti
Terminated		 KRRK070695
Aug 26, 2014Zimmer, Inc.
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
Terminated		 KRRK070695
Oct 25, 2013Zimmer, Inc.
Gender Solutions" Patello-Femoral Component
Terminated		 KRRK070695

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