Mak Oss Knee Femoral Components

Q: What is the product code of K083779?

The FDA product code is KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3510.

FDA 510(k) K083779 · Biomet Manufacturing Corp

Substantially Equivalent

510(k) numberK083779

Submission

Device name: Mak Oss Knee Femoral Components
Applicant: Biomet Manufacturing Corp
Warsaw, IN, US
Received: December 19, 2008
Decision date: April 3, 2009
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3510
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code KRO

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K261898	Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemKRO · Traditional	Howmedica Osteonics Corp. dba Stryker Orthopaedics	08/06/2026SE
K252898	Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…KRO · Traditional	Howmedica Osteonics Corp., Dba Stryker…	12/15/2025SE
K252303	Stem Extension Line (USTAR II System)KRO · Special	United Orthopedic Corporation	08/22/2025SE
K251665	Triathlon® Hinge Knee SystemKRO · Traditional	Howmedica Osteonics Corp., Dba Stryker…	07/25/2025SE
K242871	ATTUNE Revision Hinge KneeKRO · Traditional	Depuy Ireland UC	11/21/2024SE
K240043	EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral…KRO · Traditional	Microport Orthopedics, Inc.	04/01/2024SE
K233980	ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…KRO · Traditional	Depuy Ireland UC	03/21/2024SE
K230563	EVOLUTION® Hinge Knee SystemKRO · Traditional	Microport Orthopedics, Inc.	09/27/2023SE
K230416	Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®KRO · Traditional	Stryker	05/19/2023SE
K223069	Modular Rotating Hinge Knee Systems and Compatible ComponentsKRO · Traditional	Howmedica Osteonics Corp., Dba Stryker…	04/21/2023SE

More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics

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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 Mak Oss Knee Femoral Components cleared by the FDA?

Mak Oss Knee Femoral Components (K083779) received a 510(k) decision of Substantially Equivalent on April 3, 2009, 105 days after the submission was received.

What is the product code of K083779?

The FDA product code is KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3510.