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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

Company	510(k)s	Recalls
Howmedica Osteonics Corp.	4	0
Arthrosurface, Inc.	3	0
Biomet, Inc.	2	1
MEDLINE INDUSTRIES, LP - Northfield	0	3
Zimmer, Inc.	1	2
Zimmer Biomet, Inc.	0	3
Biomet Manufacturing Corp	2	0
Mako Surgical Corp.	2	0
Accelerated Innovation, LLC	1	0
Arthrex, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Feb 1, 2023	MEDLINE INDUSTRIES, LP - Northfield MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013 Open, Classified	KRR	K181280
Feb 1, 2023	MEDLINE INDUSTRIES, LP - Northfield MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008 Open, Classified	KRR	K181280
Feb 1, 2023	MEDLINE INDUSTRIES, LP - Northfield MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008 Open, Classified	KRR	K181280
Nov 29, 2017	Zimmer Biomet, Inc. ZIMMER PATELLA FEMORAL JOINT Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. Terminated	KRR	K070695
Nov 29, 2017	Zimmer Biomet, Inc. PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. Terminated	KRR	K070695
Apr 4, 2016	Biomet, Inc. All instrumentation associated with the Prelude PF Resurfacing Knee System. Terminated	KRR	K123907 K143543
Feb 22, 2016	Zimmer 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	KRR	K070695
Aug 26, 2014	Zimmer, Inc. Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis. Terminated	KRR	K070695
Oct 25, 2013	Zimmer, Inc. Gender Solutions" Patello-Femoral Component Terminated	KRR	K070695

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