Product Code: KWY FDA class 2 21 CFR 888.3390

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Orthopedic

The Metal/Polymer Cemented or Uncemented Femoral Hemi Hip Prosthesis is an orthopedic implant used to replace the femoral head component of the hip joint using a combined metal and polymer design, accommodating either cemented or press-fit fixation techniques, applied in hemiarthroplasty for hip fracture or femoral head disease. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWY, regulated under 21 CFR 888.3390, in the Orthopedic medical specialty. This device is an implant.

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510(k)s

FEI Numbers

216

Registration Numbers

216

Unique Applicants

Years Active

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Basic Information

Product Code: KWY
Device Class: FDA class 2
Regulation Number: 888.3390
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 99 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253357	b-ONE® Bipolar Head	Apr 13, 2026	Substantially Equivalent	B-One Ortho, Corp.
K243634	Maxx Libertas Bipolar Hip Head (Bipolar Hip)	Aug 25, 2025	Substantially Equivalent	Maxx Orthopedics, Inc.
K231526	CORAIL Cemented Femoral Stem	Dec 19, 2023	Substantially Equivalent	Depuy Ireland UC
K223441	SpaceFlex Acetabular Cup	Mar 23, 2023	Substantially Equivalent	G21, S.R.L.
K221794	Vario-Cup System	Jul 20, 2022	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K220492	COPAL exchange G hip spacer	Mar 23, 2022	Substantially Equivalent	Heraeus Medical GmbH
K200709	Kyocera Bipolar Hip System	Apr 17, 2020	Substantially Equivalent	Kyocera Medical Technologies, Inc.
K192236	Fitmore Hip Stem	Nov 05, 2019	Substantially Equivalent	Zimmer GmbH
K191016	COPAL exchange G Hip and Knee Spacers	Nov 01, 2019	Substantially Equivalent	Heraeus Medical GmbH
K191297	iNSitu Bipolar Hip System	Sep 17, 2019	Substantially Equivalent	Theken Companies, LLC
K191569	Implantcast ic-Bipolar Head System	Aug 28, 2019	Substantially Equivalent	Implantcast GmbH
K183114	Corin BiPolar-i	Jun 05, 2019	Substantially Equivalent	Corin U.S.A. Limited
K173455	SurgTech Bipolar Head System	Jun 14, 2018	Substantially Equivalent	Surgtech, Inc.
K180130	ELEOS Bipolar Acetabular System	Feb 23, 2018	Substantially Equivalent	Onkos Surgical, Inc.
K163081	40-42mm BiPolar Head and 22mm Femoral Head	Jan 29, 2018	Substantially Equivalent	Signature Orthopaedics Pty, Ltd.
K170072	Fitmore® Hip Stem	Feb 07, 2017	Substantially Equivalent	Zimmer GmbH
K152439	U2 Bipolar Implant and 22mm Femoral Head	Apr 07, 2016	Substantially Equivalent	United Orthopedic Corporation
K143113	Klassic BiPolar System	Jan 28, 2015	Substantially Equivalent	Total Joint Orthopedics
K132539	RING-LOK MODULAR BIPOLAR SYSTEM	Feb 07, 2014	Substantially Equivalent	Implants International, Ltd.
K131354	RENOVIS BIPOLAR HIP SYSTEM	Sep 19, 2013	Substantially Equivalent	Renovis Surgical Technologies, LLC
K123991	DEPUY CORAIL AMT HIP PROSTHESIS	Sep 16, 2013	Substantially Equivalent	Depuy France S.A.S.
K121509	TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT	Nov 05, 2012	Substantially Equivalent	Tgm Medical, Inc.
K112019	BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP	Oct 12, 2011	Substantially Equivalent	Corentec Co., Ltd.
K100761	BIOPRO POLAR HEAD	Dec 03, 2010	Substantially Equivalent	Biopro, Inc.
K101670	UNITED U2 BIPOLAR IMPLANT	Oct 08, 2010	Substantially Equivalent	United Orthopedic Corp.
K100151	APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)	May 28, 2010	Substantially Equivalent	Omnlife Science
K091967	MEDACTA BIPOLAR HEAD	Mar 02, 2010	Substantially Equivalent	Medacta International S.A.
K082468	APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)	Feb 18, 2009	Substantially Equivalent	Omni Life Science, Inc.
K082705	BIOPRO BIPOLAR HEAD, MODELS 18130-18152	Dec 15, 2008	Substantially Equivalent	Biopro, Inc.
K080979	STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT	Oct 31, 2008	Substantially Equivalent	Biomet Manufacturing Corp
K080647	ACCIN BIPOLAR HEAD SYSTEM	Jul 08, 2008	Substantially Equivalent	Accelerated Innovation, LLC
K062693	GLADIATOR BIPOLAR SYSTEM	Sep 29, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K060707	AESCULAP BIPOLAR ACETABULAR CUP	May 31, 2006	Substantially Equivalent	Aesculap, Inc.
K052990	STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM	Dec 16, 2005	Substantially Equivalent	Biomet, Inc.
K050269	U1 HIP SYSTEM - BIPOLAR	Aug 29, 2005	Substantially Equivalent	United Orthopedic Corp.
K050966	PIVOT BIPOLAR FEMORAL HEAD	Jul 07, 2005	Substantially Equivalent	Ortho Development Corp.
K040947	DURASUL BIPOLAR	Aug 27, 2004	Substantially Equivalent	Centerpulse Orthopedics, Inc.
K023743	SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM	Jan 23, 2003	Substantially Equivalent	Smith & Nephew, Inc.
K014072	FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)	Mar 08, 2002	Substantially Equivalent	Disc-O-Tech Medical Technologies, Ltd.
K013211	MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS	Dec 05, 2001	Substantially Equivalent	Exactech, Inc.
K010081	ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS	Feb 05, 2001	Substantially Equivalent	Exactech, Inc.
K003363	M2A 32MM TAPER SYSTEM	Dec 15, 2000	Substantially Equivalent	Biomet, Inc.
K991990	TRI-POLAR SYSTEM	Sep 10, 1999	Substantially Equivalent	Biomet, Inc.
K982812	G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)	Dec 04, 1998	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K982447	PLUS BIPOLAR PROSTHESIS COCRMO	Nov 25, 1998	Substantially Equivalent	Plus Orthopedics
K982389	ODC B2 BIPOLAR CUP	Oct 07, 1998	Substantially Equivalent	Ortho Development Corp.
K981238	BIPOLAR FEMORAL HEAD	Aug 21, 1998	Substantially Equivalent	Whiteside Biomechanics, Inc.
K980801	J-FX BIPOLAR HEAD	May 29, 1998	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K970447	IMPLEX BIPOLAR HIP SYSTEM	Apr 30, 1997	Substantially Equivalent	Implex Corp.
K970284	ARTOS, DIPLOS SYSTEM	Apr 21, 1997	Substantially Equivalent	Turnkey Intergration USA, Inc.
K960643	ADVANTAGE MAPF HIP FEMORAL COMPONENT	Dec 16, 1996	Substantially Equivalent	Biomet, Inc.
K963885	ULTIMA FX FEMORAL HIP STEMS	Dec 09, 1996	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K962448	PRIMALOC CEMENTED HIP SYSTEM	Sep 19, 1996	Substantially Equivalent for Some Indications	Ortho Development Corp.
K961793	BI-LOC BIPOLAR CUP	Jul 26, 1996	Substantially Equivalent	Ortho Development Corp.
K945518	P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT	Mar 08, 1996	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K953977	PRIMALOC CEMENTLESS HIP SYSTEM	Jan 26, 1996	Substantially Equivalent	Ortho Development Corp.
K940743	UHMWPE COMPONENTS-CHANGE IN PACKAGING	Sep 18, 1995	Substantially Equivalent	Depuy, Inc.
K953510	HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS	Aug 09, 1995	Substantially Equivalent	Encore Orthopedics, Inc.
K945793	P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR	Apr 10, 1995	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K941534	MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM	Mar 06, 1995	Substantially Equivalent	3M Health Care, Ltd.
K944132	P.F.C. TOTAL HIP SYSTEM	Jan 06, 1995	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K934159	IOI COCR UNIPOLAR PROSTHESIS	Jul 21, 1994	Substantially Equivalent	Intermedics Orthopedics
K931655	P.F.C. BIPOLAR HIP SYSTEM	Jun 09, 1994	Substantially Equivalent	Johnson & Johnson Orthopaedics, Inc.
K925153	IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM	Mar 01, 1994	Substantially Equivalent	Howmedica Corp.
K926387	TECHMEDICA STANDARD CEMENTED HIP SYSTEM	Feb 01, 1994	Substantially Equivalent	Techmedica, Inc.
K925536	HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM	Jan 07, 1994	Substantially Equivalent for Some Indications	Orthomet, Inc.
K925420	TECHMEDICA STANDARD BIPOLAR SYSTEM	Sep 28, 1993	Substantially Equivalent	Techmedica, Inc.
K925897	CORIN BIPOLAR PROSTHESIS	Aug 09, 1993	Substantially Equivalent	Corin Orthopedic Products
K922560	CONSENSUS(TM) BIPOLAR SYSTEM	Sep 11, 1992	Substantially Equivalent	U.S. Medical Products, Inc.
K913632	BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM	Nov 13, 1991	Substantially Equivalent	Kirschner Medical Corp.
K905370	EXACTECH BIPOLAR HIP PROSTHESIS	Feb 27, 1991	Substantially Equivalent	Exactech, Inc.
K904383	ACUFIT TOTAL HIP	Dec 20, 1990	Substantially Equivalent	Acu Med, Inc.
K900051	MOORE TYPE ENDO PROSTHESIS	Oct 03, 1990	Substantially Equivalent	Lima Intl. Corp.
K896257	LEINBACH HIP PROSTHESIS	Jan 19, 1990	Substantially Equivalent	3M Company
K895120	BATEMAN UPF II HIP PROSTHESIS SYSTEM	Jan 11, 1990	Substantially Equivalent	3M Company
K896266	VS22 HIP PROSTHESIS	Nov 22, 1989	Substantially Equivalent	3M Company
K893872	P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT	Sep 11, 1989	Substantially Equivalent for Some Indications	Johnson & Johnson Professionals, Inc.
K893959	P.S.A. FEMORAL HIP PROSTHESIS	Jul 25, 1989	Substantially Equivalent	Protek, Inc.
K884658	ZIMMER BEADED THREADED ACETABULAR CUP	Nov 30, 1988	Substantially Equivalent	Zimmer, Inc.
K881289	CORIN BIPOLAR PROSTHESIS	Jun 29, 1988	Substantially Equivalent	Orthopedic Systems, Inc.
K873815	IOI BIPOLAR PROSTHESIS	Oct 28, 1987	Substantially Equivalent	Intermedics Orthopedics
K873514	JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS	Sep 24, 1987	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K872019	BI-ARTICULAR II HIP DEVICE	Jul 21, 1987	Substantially Equivalent	Zimmer, Inc.
K862460	FEMORAL HEMI-HIP PROSTHESIS	Oct 06, 1986	Substantially Equivalent	Orthopaedic Device Corp.
K862057	KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD	Jul 11, 1986	Substantially Equivalent	Kirschner Medical Corp.
K861566	SLR BIPOLAR HIP ENDOPROSTHESIS	May 12, 1986	Substantially Equivalent	Dow Corning Wright
K861105	HOWMEDICA BIPOLAR PROSTHESIS	Apr 14, 1986	Substantially Equivalent	Howmedica Corp.
K855231	HOWMEDICA BIPOLAR PROSTHESIS	Feb 27, 1986	Substantially Equivalent	Howmedica Corp.
K853795	KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD	Nov 22, 1985	Substantially Equivalent	Kirschner Medical Corp.
K842344	HASTINGS BIPOLAR ENDOPROSTHESIS	Sep 12, 1984	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K833404	BDH BIPOLAR FEMORAL COMPONENT A3	Mar 02, 1984	Substantially Equivalent	Carbomedics, Inc.
K833991	BIPOLAR HIP DEVICE	Jan 30, 1984	Substantially Equivalent	Zimmer
K833175	BIOMET BIPOLAR PROSTHESIS	Dec 22, 1983	Substantially Equivalent	Biomet, Inc.
K823726	SPECTRON CONVERSION ENDOPROSTHESIS CUP	Mar 09, 1983	Substantially Equivalent	Richard'S Medical Equip., Inc.
K823482	101 UNIVERSAL ENDOPROSTHESIS	Feb 07, 1983	Substantially Equivalent	Intermedics Orthopedics
K812672	SELF-CENTERING HIP	Oct 08, 1981	Substantially Equivalent	Depuy, Inc.
K810062	BI-CENTRIC BI-POLAR ENDOPROSTHESIS	Jan 26, 1981	Substantially Equivalent	Howmedica Corp.
K791823	3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM	Oct 30, 1979	Substantially Equivalent	3M Company
K781735	ENDOPROSTHESIS SYSTEM, VARIO-HEAD	Oct 24, 1978	Substantially Equivalent	Waldemar Link GmbH & Co. KG