Product Code: KWL FDA class 2 21 CFR 888.3360

Prosthesis, Hip, Hemi-, Femoral, Metal

Orthopedic

The Metal Femoral Hemi Hip Prosthesis is an orthopedic implant used to replace the femoral head and neck of the hip joint with a metal component, applied in cases of femoral neck fractures or isolated femoral head disease where the acetabulum remains intact. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWL, regulated under 21 CFR 888.3360, in the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

107

FEI Numbers

149

Registration Numbers

149

Unique Applicants

Years Active

Research product code KWL in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: KWL
Device Class: FDA class 2
Regulation Number: 888.3360
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 107 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260536	Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement	May 15, 2026	Substantially Equivalent	Depuy Ireland UC
K253675	OsteoRemedies Hip Spacer System	Dec 23, 2025	Substantially Equivalent	Osteoremedies, LLC
K252326	InterSpace GV Hip Spacer	Aug 06, 2025	Substantially Equivalent	Tecres S.P.A.
K242865	Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer	Jun 12, 2025	Substantially Equivalent	Biocomposites, Ltd.
K234028	COPAL® exchange G hip spacer; COPAL® G+V	Feb 15, 2024	Substantially Equivalent	Heraeus Medical GmbH
K222632	UHR Bipolar Implants, Restoration GAP II Implants	Oct 21, 2022	Substantially Equivalent	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
K192995	OsteoRemedies Hip Spacer System	Jan 10, 2020	Substantially Equivalent	Osteoremedies, LLC
K191981	REMEDY Acetabular Cup	Aug 23, 2019	Substantially Equivalent	Osteoremedies, LLC
K172906	REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement	Aug 29, 2018	Substantially Equivalent	Osteoremedies, LLC
K173967	Remedy Acetabular Cup	Feb 22, 2018	Substantially Equivalent	Osteoremedies, LLC
K143184	Evolve UniPolar Head	Mar 17, 2015	Substantially Equivalent	Signature Orthopaedics Pty, Ltd.
K112470	2GC HIP/KNEE MODULAR SPACER	Apr 05, 2012	Substantially Equivalent	Mandell Horwitz Consultants, LLC
K101356	Spacer-G and Spacer-K	Sep 20, 2011	Substantially Equivalent	Tecres S.P.A.
K111911	CORIN OPTIMOM MODULAR HEAD	Aug 04, 2011	Substantially Equivalent	Corin USA
K062273	SPACER-G TEMPORARY HIP PROSTHESIS	May 22, 2008	Substantially Equivalent	Tecres S.P.A.
K071471	CORIN ADAPTOR SLEEVE	Sep 10, 2007	Substantially Equivalent	Howmedica Osteonics Corp.
K063791	CORIN UNIPOLAR MODULAR HEAD	Apr 03, 2007	Substantially Equivalent	Corin USA
K062408	SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD	Sep 12, 2006	Substantially Equivalent	Smith & Nephew, Inc.
K061243	SMITH & NEPHEW MODULAR FEMORAL HEAD	Jul 17, 2006	Substantially Equivalent	Smith & Nephew, Inc.
K042973	SOLITUDE UNIPOLAR HEAD	Jan 27, 2005	Substantially Equivalent	Ortho Development Corp.
K031841	SPACER G TEMPORARY HIP PROSTHESIS	Jan 22, 2004	Substantially Equivalent	Exactech, Inc.
K030972	FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)	May 30, 2003	Substantially Equivalent	Disc-O-Tech Medical Technologies, Ltd.
K030205	CONSENSUS UNIPOLAR HEAD, COCR	Apr 01, 2003	Substantially Equivalent	Hayes Medical, Inc.
K014226	UNITRAX MODULAR UNIPOLAR SYSTEM	Jan 25, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K992570	UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE	Sep 01, 1999	Substantially Equivalent	Howmedica Osteonics Corp.
K990309	PLUS FRACTURE HEAD PROSTHESIS	Mar 15, 1999	Substantially Equivalent	Plus Orthopedics
K984585	OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE	Feb 24, 1999	Substantially Equivalent	Osteonics Corp.
K984028	THE NEW BIO-MOORE ENDO HEADS	Jan 19, 1999	Substantially Equivalent	Biomet, Inc.
K981451	ARGOMEDICAL BIPOLAR SYSTEM	Aug 21, 1998	Substantially Equivalent	Stelkast Company
K974807	OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM	Mar 16, 1998	Substantially Equivalent	Osteonics Corp.
K973614	FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES	Dec 18, 1997	Substantially Equivalent	Encore Orthopedics, Inc.
K965198	ULTIMA TPS CEMENTED STEM	Jul 23, 1997	Substantially Equivalent	Johnson & Johnson International
K965156	ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES	Jan 24, 1997	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K962646	PRIME MODULAR ENDO HEAD	Sep 23, 1996	Substantially Equivalent	Orthopaedic Innovations, Inc.
K960538	OPTEON UNIPOLAR	Mar 27, 1996	Substantially Equivalent	Exactech, Inc.
K955385	JOHNSON & JOHNSON AUSTIN MOORE STEM	Jan 30, 1996	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K954534	OSTEONICS UNIPOLAR ENDO HEAD	Nov 30, 1995	Substantially Equivalent	Osteonics Corp.
K954077	UNITRAX V40 MODULAR ADAPTOR	Nov 15, 1995	Substantially Equivalent	Howmedica Corp.
K943778	OSTEONICS RESTORATION CEMENTED HIP STEM SERIES	Aug 14, 1995	Substantially Equivalent	Osteonics Corp.
K950563	ULTIMA AUGMENTED UHMWPE CUP	Jun 07, 1995	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K951355	LINK SADDLE PROTHESIS	May 25, 1995	Substantially Equivalent	Turnkey Intergration USA, Inc.
K931753	CORIN THOMPSON PROSTHESIS, MODIFICATION	Oct 07, 1994	Substantially Equivalent for Some Indications	Corin Orthopedic Products
K931752	CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION	Oct 07, 1994	Substantially Equivalent	Corin Orthopedic Products
K940190	ULTIMA UNIPOLAR MODULAR HEAD	Sep 29, 1994	Substantially Equivalent	Johnson & Johnson Orthopaedics, Inc.
K934353	ZIRCONIUM ALLOY UNI-POLAR HEAD	Apr 25, 1994	Substantially Equivalent	Smith & Nephew Richards, Inc.
K924050	TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT	Aug 25, 1993	Substantially Equivalent	Orthomet, Inc.
K926120	CONTOUR FEMORAL HIP STEM WITH POROCOAT	Mar 31, 1993	Substantially Equivalent	Depuy, Inc.
K924379	ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM	Feb 12, 1993	Substantially Equivalent	Johnson & Johnson Orthopaedics, Inc.
K922146	OSTRONCS HEMI-HIP STEM SERIES	Aug 11, 1992	Substantially Equivalent	Osteonics Corp.
K920231	OMNIFIT M-HA HIP STEM SERIES	Jun 08, 1992	Substantially Equivalent	Stryker Corp.
K920193	OMNIFLEX M-HA HIP STEM SERIES	Jun 08, 1992	Substantially Equivalent	Stryker Corp.
K915868	PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT	Mar 23, 1992	Substantially Equivalent	Orthomet, Inc.
K903877	MTS FEMORAL HIP SYSTEM	Jan 18, 1991	Substantially Equivalent	3M Company
K902365	MODULAR UNIPOLAR SYSTEM	Jan 11, 1991	Substantially Equivalent	Howmedica Corp.
K905349	AUSTIN MOORE TYPE HIP PROTHESIS	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K905334	THOMPSON TYPE HIP PROSTHESIS	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K904119	PROFILE COLLARED HIP PROSTHESIS	Oct 11, 1990	Substantially Equivalent for Some Indications	Depuy, Inc.
K903885	KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD	Sep 13, 1990	Substantially Equivalent	Kinamed, Inc.
K903884	KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD	Sep 13, 1990	Substantially Equivalent	Kinamed, Inc.
K903241	AUSTIN MOORE TYPE HIP PROSTHESIS	Jul 30, 1990	Substantially Equivalent	Onyx Medical Corp.
K903240	THOMPSON TYPE HIS PROSTHESIS	Jul 30, 1990	Substantially Equivalent	Onyx Medical Corp.
K896853	PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA	May 02, 1990	Substantially Equivalent for Some Indications	Howmedica Corp.
K900638	P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT	Apr 30, 1990	Substantially Equivalent	Johnson & Johnson International
K896105	EVOLUTION HIP SYSTEM	Dec 29, 1989	Substantially Equivalent for Some Indications	Dow Corning Wright
K895886	BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM	Dec 01, 1989	Substantially Equivalent	Biopro, Inc.
K891482	AML(R) COLLARLESS LATERALIZED FEMORAL HIP	May 16, 1989	Substantially Equivalent for Some Indications	Depuy, Inc.
K884889	MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.	Feb 27, 1989	Substantially Equivalent	Protek, Inc.
K884789	NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI	Feb 08, 1989	Substantially Equivalent for Some Indications	Protek, Inc.
K883179	HIP FRACTURE STEM SYSTEM	Sep 22, 1988	Substantially Equivalent	Howmedica Corp.
K874915	ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS	Feb 03, 1988	Substantially Equivalent	Orthomet, Inc.
K872535	BIOPRO FEMORAL HIP COMPONENT	Aug 26, 1987	Substantially Equivalent	Biopro, Inc.
K872776	PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT	Aug 24, 1987	Substantially Equivalent for Some Indications	Depuy, Inc.
K872025	POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS	Aug 18, 1987	Substantially Equivalent for Some Indications	Depuy, Inc.
K872878	TRI-LOCK MODIFIED FEMORAL PROSTHESIS	Aug 07, 1987	Substantially Equivalent for Some Indications	Depuy, Inc.
K871656	ORTHOMET AUSTIN-MOORE SYSTEM	Jun 09, 1987	Substantially Equivalent	Orthomet, Inc.
K864085	BROOKER BIO-GROOVE FEMORAL COMPONENT	Jan 28, 1987	Substantially Equivalent	Biomet, Inc.
K854791	BIO-FIT HIP SYSTEM	Feb 27, 1986	Substantially Equivalent	Richards Medical Co., Inc.
K855228	FEMORAL HEMI-HIP PROSTHESES	Feb 11, 1986	Substantially Equivalent	Orthopaedic Device Corp.
K853662	MUELLER CURVED STEM HEMI-PROSTHESIS	Sep 24, 1985	Substantially Equivalent	Protek, Inc.
K852584	POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT	Aug 15, 1985	Substantially Equivalent	Biomet, Inc.
K844818	NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS	Jul 30, 1985	Substantially Equivalent	Osteonics Corp.
K852420	BTM TOTAL HIP SYSTEM	Jun 28, 1985	Substantially Equivalent	Kirschner Medical Corp.
K850928	V.E.P. HIP -VARIABLE ENDO-PROSTHESIS	May 28, 1985	Substantially Equivalent	Unitas Ent.
K843995	TF-II HIP PROSTHESIS	Apr 23, 1985	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials
K845025	AUSTIN-MOORE MODULAR HIP PROSTHESIS	Apr 19, 1985	Substantially Equivalent	Biomet, Inc.
K844488	MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS	Mar 12, 1985	Substantially Equivalent	Mecron Medical Products, Inc.
K844487	MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR	Feb 19, 1985	Substantially Equivalent	Mecron Medical Products, Inc.
K844486	MECRON MRC-HEADLESS FEMORAL COMPONENT	Feb 19, 1985	Substantially Equivalent	Mecron Medical Products, Inc.
K842559	WHITESIDE ORTHOLOC TOTAL HIP FEMORAL	Dec 20, 1984	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials
K842465	UNILOC	Nov 19, 1984	Substantially Equivalent	American Ortomed Corp.
K842234	NEW JERSEY FEMORAL STEM	Jul 20, 1984	Substantially Equivalent	Endomedics, Inc.
K841437	PENNSYLVANIA HOSPITAL HIP SYS	Jun 25, 1984	Substantially Equivalent	Biomet, Inc.
K833599	MODIFIED HPS HIP PROSTHESIS	Mar 19, 1984	Substantially Equivalent	Depuy, Inc.
K833403	BDH UNIPOLAR FEMORAL COMPONENT A2	Jan 10, 1984	Substantially Equivalent	Carbomedics, Inc.
K831851	STRAIGHT STEM FEMORAL HEAD PROSTHESIS	Oct 06, 1983	Substantially Equivalent	Proteck, Inc.
K831420	HIP PROSTHESIS -VARIOUS	Sep 20, 1983	Substantially Equivalent	The Oec Group
K830307	AUFRANC-TURNER ATS TOTAL HIP SYSTEM	Mar 10, 1983	Substantially Equivalent	Howmedica Corp.
K823051	METAL KNEE & HIP PROSTHESIS	Dec 03, 1982	Substantially Equivalent	Zimmer, Inc.
K822321	IOI 32 TM FEMORAL COMPONENT	Aug 20, 1982	Substantially Equivalent	Intermedics Orthopedics
K822320	KAMPNER FEMORAL COMPONENT	Aug 19, 1982	Substantially Equivalent	Intermedics Orthopedics
K820755	THE ORIGINAL LEINBACH PLATFORM TOTAL HIP	Jun 10, 1982	Substantially Equivalent	Allo Pro Corp.
K821343	BDH FEMORAL COMPONENT	Jun 03, 1982	Substantially Equivalent	Intermedics Orthopedics
K811416	MOORE HIP PROSTHESIS, PMMA COATED	Aug 12, 1981	Substantially Equivalent	Zimmer, Inc.
K811738	COLLARLESS TAPERED STEM HIP PROSTH. DEV	Jul 20, 1981	Substantially Equivalent	Biomet, Inc.
K803191	PROSTHESIS, HIP FEMORAL COMPONENT METAL	Jan 23, 1981	Substantially Equivalent	Osteonics Corp.
K800207	UHR UNIVERSAL6HIP REPLACEMENT	Feb 11, 1980	Substantially Equivalent	Osteonics Corp.
K792181	3M HS 22 FEMORAL COMPONENT	Nov 15, 1979	Substantially Equivalent	3M Company