Product Code: KXA FDA class 2 21 CFR 888.3400

Prosthesis, Hip, Femoral, Resurfacing

Orthopedic

The Femoral Resurfacing Hip Prosthesis is an orthopedic implant used in hip resurfacing arthroplasty, in which only the surface of the femoral head is capped and reshaped rather than fully replaced, preserving more native bone stock compared to total hip replacement. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification prior to marketing. The product code is KXA, regulated under 21 CFR 888.3400, in the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: KXA
Device Class: FDA class 2
Regulation Number: 888.3400
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K201219	Biocore9 Femoral Head Resurfacing Component	Jan 19, 2021	Substantially Equivalent	Biocore9, LLC
K092198	CORMET CEMENTLESS RESURFACING FEMORAL HEAD	Apr 15, 2010	Substantially Equivalent	Corin USA
K082673	CONSERVE PRESSFIT FEMORAL COMPONENT	Dec 12, 2008	Substantially Equivalent	Wrightmedicaltechnologyinc
K071053	RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD	Jun 29, 2007	Substantially Equivalent	Biomet, Inc.
K070292	DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS	Apr 26, 2007	Substantially Equivalent	Zimmer GmbH
K062960	CONSERVE FEMORAL RESURFACING COMPONENT	Dec 01, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K043542	BIOPRO TARA FEMORAL RESURFACING COMPONENT	May 18, 2005	Substantially Equivalent	Biopro, Inc.
K032659	DEPUY ASR RESURFACING FEMORAL HEADS	Dec 04, 2003	Substantially Equivalent	DePuy Orthopaedics, Inc.
K023188	PRESS-FIT HEAD RESURFACING DEVICE	Dec 11, 2002	Substantially Equivalent	Biomet Orthopedics, Inc.
K021549	CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM	Aug 01, 2002	Substantially Equivalent	Std Mfg., Inc.
K021799	CEMENTED FEMORAL HEAD RESURFING DEVICE	Jun 26, 2002	Substantially Equivalent	Biomet Orthopedics, Inc.
K994153	CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS	Feb 25, 2000	Substantially Equivalent	Corin USA
K983452	NELSON RESURFACING HEAD	Dec 03, 1998	Substantially Equivalent	Biomet, Inc.
K950998	MODUILAR UNIPOLAR	Apr 13, 1995	Substantially Equivalent	Intermedics Orthopedics
K944752	ORTHOMET RESURFACING FEMORAL COMPONENT	Dec 28, 1994	Substantially Equivalent	Orthomet, Inc.
K904870	MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON	May 23, 1991	Substantially Equivalent	Endotec, Inc.
K894604	BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT	Nov 17, 1989	Substantially Equivalent for Some Indications	Biopro, Inc.
K892398	BIPOLAR HIP SYSTEM	May 23, 1989	Substantially Equivalent	Orthomet, Inc.
K883212	LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT	Nov 22, 1988	Substantially Equivalent	Implant Technology, Inc.
K842233	NEW JERSEY FEMORAL RESURFACING COMPONENT	Jul 20, 1984	Substantially Equivalent	Endomedics, Inc.
K792200	TILLMAN HIP RESURFACING REPLACEMT PROS.	Dec 05, 1979	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K781490	TILLMAN HIPSURFACE REPLACEMENT	Sep 20, 1978	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K761324	RESURFACE PROSTHESES FOR HIP JOINT	Jan 05, 1977	Substantially Equivalent	Holco Instrument Corp.