Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella Components,

Q: What is the product code of K123907?

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) K123907 · Biomet Manufacturing Corp

Substantially Equivalent

510(k) numberK123907

Submission

Device name: Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella Components,
Applicant: Biomet Manufacturing Corp
Warsaw, IN, US
Received: December 19, 2012
Decision date: September 3, 2013
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
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
K080029	Mako Surgical Corp. Patellofemoral Knee Implant SystemKRR · Traditional	Mako Surgical Corp.	05/16/2008SE

More from Mako Surgical Corp.

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K214001	Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemPHX · Traditional	03/15/2023SE
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 Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella Components, cleared by the FDA?

Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo), Prelude PF Patella Components, (K123907) received a 510(k) decision of Substantially Equivalent on September 3, 2013, 258 days after the submission was received.

What is the product code of K123907?

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.