Patient Matched Cobalt Alloy Trochlea Replacement

Q: What is the product code of K001374?

The FDA product code is KRR – Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3540.

FDA 510(k) K001374 · Biomet Manufacturing, Inc.

Substantially Equivalent

510(k) numberK001374

Submission

Device name: Patient Matched Cobalt Alloy Trochlea Replacement
Applicant: Biomet Manufacturing, Inc.
Warsaw, IN, US
Received: May 1, 2000
Decision date: July 27, 2000
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KRR – Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3540
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code KRR

510(k)	Device	Applicant	Decision
K231253	Overture Orthopaedics Patellofemoral SystemKRR · Traditional	Overture Resurfacing, Inc.	07/07/2023SE
K221048	Episealer Patellofemoral SystemKRR · Traditional	Episurf Medical, Inc.	12/23/2022SE
K211303	Avon Patello-femoral Joint ProsthesisKRR · Traditional	Howmedica Osteonics Corp., Dba Stryker…	06/04/2021SE
K200122	MOTO PFJ SystemKRR · Traditional	Medacta International S.A.	04/20/2020SE
K181280	Patello-Femoral Wave (Kahuna) Arthroplasty SystemKRR · Special	Arthrosurface, Inc.	06/14/2018SE
K160461	Arthrex iBalance BiCompartmental Arthroplasty SystemKRR · Traditional	Arthrex, Inc.	04/12/2016SE
K143543	Prelude PF PatellaeKRR · Traditional	Biomet, Inc.	01/30/2015SE
K123907	Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…KRR · Traditional	Biomet Manufacturing Corp	09/03/2013SE
K111970	Kneetec Pfj&Hls Kneetec Patellar ComponentKRR · Traditional	Tornier	02/23/2012SE
K082088	Mako Surgical Corp. Patellofemoral Knee Implant System IIKRR · Traditional	Mako Surgical Corp.	10/22/2008SE

More from Mako Surgical Corp.

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K211729	Comprehensive® Convertible Glenoid - Vivacit-E LinerPHX · Traditional	11/04/2021SE
K202232	Comprehensive Vault Reconstruction SystemPHX · Traditional	02/19/2021SE
K193038	Comprehensive Shoulder SystemMBF · Traditional	10/28/2020SE
K182516	Comprehensive Nano Stemless ShoulderPKC · Traditional	04/22/2019SE
K181611	Comprehensive Reverse Shoulder SystemPHX · Traditional	09/24/2018SE
K173411	Comprehensive Segmental Revision System (SRS)PHX · Traditional	02/08/2018SE
K172502	Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…PHX · Traditional	01/03/2018SE
K163651	ExpressBraid Graft ManipulationGAT · Traditional	02/17/2017SE

Questions and answers

When was Patient Matched Cobalt Alloy Trochlea Replacement cleared by the FDA?

Patient Matched Cobalt Alloy Trochlea Replacement (K001374) received a 510(k) decision of Substantially Equivalent on July 27, 2000, 87 days after the submission was received.

What is the product code of K001374?

The FDA product code is KRR – Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3540.