Bohn Femoral Component

Q: What is the product code of K000262?

The FDA product code is MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a Class II (moderate risk) device regulated under 21 CFR 888.3353.

FDA 510(k) K000262 · Biomet Manufacturing, Inc.

Substantially Equivalent

510(k) numberK000262

Submission

Device name: Bohn Femoral Component
Applicant: Biomet Manufacturing, Inc.
Warsaw, IN, US
Received: January 28, 2000
Decision date: April 3, 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: MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3353
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code MEH

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K261576	Icona Hip StemMEH · Traditional	Corin, Ltd.	08/10/2026SE
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K251166	Mfinity Femoral SystemMEH · Traditional	Medacta International S.A.	06/13/2025SE
K251052	Trivicta® Hip StemMEH · Traditional	Ortho Development Corp.	05/22/2025SE
K242315	Resolve Modular Revision Hip StemMEH · Traditional	United Orthopedic Corporation	05/01/2025SE
K243839	Alteon® HA Femoral StemsMEH · Traditional	Exactech, Inc.	03/10/2025SE
K243162	World LinerMEH · Special	Signature Orthopaedics Pty, Ltd.	11/25/2024SE
K241472	Icona Hip StemMEH · Traditional	Corin U.S.A. Limited	10/03/2024SE
K241875	TheRay Collared and Collarless Femoral StemMEH · Traditional	Nextstep Arthropedix	09/13/2024SE
K241690	Logical Liner; World Liner; World Knee PatellaMEH · Special	Signature Orthopaedics Pty, Ltd.	08/01/2024SE

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K173411	Comprehensive Segmental Revision System (SRS)PHX · Traditional	02/08/2018SE
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Questions and answers

When was Bohn Femoral Component cleared by the FDA?

Bohn Femoral Component (K000262) received a 510(k) decision of Substantially Equivalent on April 3, 2000, 66 days after the submission was received.

What is the product code of K000262?

The FDA product code is MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a Class II (moderate risk) device regulated under 21 CFR 888.3353.