KRR · Class II · 21 CFR 888.3540

FDA Product Code KRR: Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

Leading manufacturers include Howmedica Osteonics Corp., Biomet, Inc. and Overture Resurfacing, Inc..

27
Total
27
Cleared
108d
Avg days
1996
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer Devices (Product Code KRR)

27 devices
1–24 of 27
Cleared Jul 07, 2023
Overture Orthopaedics Patellofemoral System
K231253
Overture Resurfacing, Inc.
Orthopedic · 67d
Cleared Dec 23, 2022
Episealer Patellofemoral System
K221048
Episurf Medical, Inc.
Orthopedic · 259d
Cleared Jun 04, 2021
Avon Patello-femoral Joint Prosthesis
K211303
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 36d
Cleared Apr 20, 2020
MOTO PFJ System
K200122
Medacta International S.A.
Orthopedic · 90d
Cleared Jun 14, 2018
Patello-Femoral Wave (Kahuna) Arthroplasty System
K181280
Arthrosurface, Inc.
Orthopedic · 30d
Cleared Apr 12, 2016
Arthrex iBalance BiCompartmental Arthroplasty System
K160461
Arthrex, Inc.
Orthopedic · 53d
Cleared Jan 30, 2015
Prelude PF Patellae
K143543
Biomet, Inc.
Orthopedic · 46d
Cleared Jun 07, 2007
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
K070695
Zimmer, Inc.
Orthopedic · 86d
Cleared Oct 21, 2005
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K051948
Howmedica Osteonics Corp.
Orthopedic · 95d
Cleared May 31, 2005
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
K051086
Smith & Nephew, Inc.
Orthopedic · 33d
Cleared May 27, 2004
AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
K041160
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Apr 11, 2002
AVON PATELLAR COMPONENT
K020841
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 06, 2001
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K010100
Howmedica Osteonics Corp.
Orthopedic · 85d
Cleared Jul 26, 2000
PATIENT MATCHED TITANIUM ALLOY TROCHLEA
K001350
Biomet, Inc.
Orthopedic · 89d

About Product Code KRR - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code KRR since 1996, with 27 receiving FDA clearance (average review time: 108 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.