Product Code: KWA FDA class 3 21 CFR 888.3330

Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Orthopedic

The Hip Semi-Constrained Metal Uncemented Acetabular Component Prosthesis is a surgical implant designed to resurface or replace the acetabular (socket) side of the hip joint without the use of bone cement, relying on bone ingrowth or press-fit fixation. It is classified as FDA Class 3, the highest risk level, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness before commercial distribution. The product code is KWA, regulated under 21 CFR 888.3330, in the Orthopedic medical specialty. This device is an implant.

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510(k)s

114

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KWA
Device Class: FDA class 3
Regulation Number: 888.3330
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 2

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 114 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K122778	PROFEMUR Z REVISION HIP STEM	Oct 11, 2012	Substantially Equivalent	Wrightmedicaltechnologyinc
K121544	DYNASTY BIOFOAM SHELL	Jul 30, 2012	Substantially Equivalent	Wrightmedicaltechnologyinc
K113271	METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS	May 18, 2012	Substantially Equivalent	Biomet Manufacturing, Inc.
K113322	CONSERVE THIN SHELL	Feb 03, 2012	Substantially Equivalent	Wrightmedicaltechnologyinc
K112080	PRESERVE HIP STEM	Dec 28, 2011	Substantially Equivalent	Wrightmedicaltechnologyinc
K112150	PROFEMUR GLADIATOR HA HIP STEM	Nov 23, 2011	Substantially Equivalent	Wrightmedicaltechnologyinc
K113019	PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER	Nov 10, 2011	Substantially Equivalent	Wrightmedicaltechnologyinc
K111910	GLADIATOR HIP STEM	Oct 14, 2011	Substantially Equivalent	Wrightmedicaltechnologyinc
K110836	CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY	Oct 07, 2011	Substantially Equivalent	Zimmer GmbH
K110400	TAPERLOC COMPLETE MICROPLASTY STEM	Sep 30, 2011	Substantially Equivalent	Biomet Manufacturing Corp
K111699	PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM	Aug 19, 2011	Substantially Equivalent	Wrightmedicaltechnologyinc
K111698	PROFEMUR(R) E CEMENTLESS HIP STEM	Aug 19, 2011	Substantially Equivalent	Wrightmedicaltechnologyinc
K110399	GLADIATOR PLASMA CLASSIC HIP STEM	May 10, 2011	Substantially Equivalent	Wrightmedicaltechnologyinc
K110029	CONSERVE BIO FOAM SHELL	Apr 19, 2011	Substantially Equivalent	Wrightmedicaltechnologyinc
K103755	TAPERLOC COMPLETE, SIZE 5 AND 6	Jan 21, 2011	Substantially Equivalent	Biomet Manufacturing Corp
K102565	ANTERIOR APPROACH HIP SURGERY INSTRUMENTS	Dec 22, 2010	Substantially Equivalent	Wrightmedicaltechnologyinc
K100469	ARCOS INTERLOCKING DISTAL STEMS	Dec 07, 2010	Substantially Equivalent	Biomet Manufacturing Corp
K101086	TAPERLOC COMPLETE	Sep 03, 2010	Substantially Equivalent	Biomet, Inc.
K101475	COMPRESS ANTI-ROTATION SPINDLES	Jun 18, 2010	Substantially Equivalent	Biomet Manufacturing Corp
K093235	RINGLOC + HYBRID ACETABULAR SYSTEM	Apr 30, 2010	Substantially Equivalent	Biomet, Inc.
K092331	DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;	Mar 03, 2010	Substantially Equivalent	Encore Medical L.P.
K091003	ZIMMER MMC CUP	Nov 24, 2009	Substantially Equivalent	Zimmer GmbH
K091973	METASUL TAPER LINERS, METASUL FEMORAL HEADS	Nov 17, 2009	Substantially Equivalent	Zimmer GmbH
K090757	BIOMET MODULAR FEMORAL REVISION SYSTEM	Sep 25, 2009	Substantially Equivalent	Biomet, Inc.
K091423	PROFEMUR HIP SYSTEM MODULAR NECKS	Aug 25, 2009	Substantially Equivalent	Wrightmedicaltechnologyinc
K083651	REVELATION STEM, MODEL 427-21/42-080/180	Mar 13, 2009	Substantially Equivalent	Encore Medical L.P.
K083642	DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS	Mar 06, 2009	Substantially Equivalent	DePuy Orthopaedics, Inc.
K082924	DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER	Mar 06, 2009	Substantially Equivalent	Wrightmedicaltechnologyinc
K082585	DEPUY ASPHERE M-SPEC HEAD	Dec 04, 2008	Substantially Equivalent	DePuy Orthopaedics, Inc.
K082446	BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS	Oct 15, 2008	Substantially Equivalent	Biomet, Inc.
K080991	DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM	Jul 02, 2008	Substantially Equivalent	DePuy Orthopaedics, Inc.
K081090	PROFEMUR LX 5/8 COATED HIP STEM	May 15, 2008	Substantially Equivalent	Wrightmedicaltechnologyinc
K081007	ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM	May 06, 2008	Substantially Equivalent	Zimmer, Inc.
K080663	PROFEMUR LX REVISION 5/8 COATED HIP STEM	Apr 08, 2008	Substantially Equivalent	Wrightmedicaltechnologyinc
K073637	PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS	Mar 20, 2008	Substantially Equivalent	Biomet Manufacturing Corp
K071723	ZIMMER POROLOCK MIS STEM	Mar 07, 2008	Substantially Equivalent	Zimmer GmbH
K073413	DEPUY ASR 300 ACETABULAR CUP SYSTEM	Jan 30, 2008	Substantially Equivalent	DePuy Orthopaedics, Inc.
K071856	ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES	Jul 30, 2007	Substantially Equivalent	Zimmer, Inc.
K070221	FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38	Apr 04, 2007	Substantially Equivalent	Encore Medical L.P.
K070274	ECHO BI-METRIC PRESS-FIT STEMS	Apr 03, 2007	Substantially Equivalent	Biomet Manufacturing Corp
K062994	LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS	Mar 09, 2007	Substantially Equivalent	Biomet Manufacturing Corp
K070359	DEPUY ASR TAPER SLEEVE ADAPTER	Mar 06, 2007	Substantially Equivalent	DePuy Orthopaedics, Inc.
K063614	ALTRA FX HIP SYSTEM	Feb 20, 2007	Substantially Equivalent	Biomet Manufacturing Corp
K063251	ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY	Jan 24, 2007	Substantially Equivalent	Zimmer, Inc.
K062998	COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)	Jan 19, 2007	Substantially Equivalent	Biomet Manufacturing Corp
K062426	DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS	Dec 15, 2006	Substantially Equivalent	DePuy Orthopaedics, Inc.
K063414	MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38	Dec 12, 2006	Substantially Equivalent	Encore Medical L.P.
K063002	ALTRA PRESS-FIT HIP SYSTEM	Oct 31, 2006	Substantially Equivalent	Biomet Manufacturing Corp
K062995	M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT	Oct 31, 2006	Substantially Equivalent	Biomet Manufacturing Corp
K061221	DUPUY S-ROM STD HIP STEM PROSTHESIS	Aug 28, 2006	Substantially Equivalent	DePuy Orthopaedics, Inc.
K061423	M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS	Jul 27, 2006	Substantially Equivalent	Biomet Manufacturing Corp
K060358	PROFEMUR TL HIP STEM	May 10, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K060356	CONSERVE PLUS QUADRAFIX ACETABULAR SHELL	Apr 18, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K053536	DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS	Mar 16, 2006	Substantially Equivalent	Zimmer GmbH
K052915	PROFEMUR XTR HIP STEM	Jan 27, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K053588	PROFEMUR LX HIP STEM	Jan 13, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K052320	ENCORE CLP OFFSET TOTAL HIP SYSTEM	Dec 30, 2005	Substantially Equivalent	Encore Medical Corporation
K052888	POROUS TITANIUM ACETABULAR AUGMENTS	Dec 06, 2005	Substantially Equivalent	Biomet Manufacturing Corp
K050124	POROUS COATED ACETABULAR COMPONENTS	Oct 04, 2005	Substantially Equivalent	Biomet, Inc.
K043099	LINEAGE HA ACETABULAR SHELLS	Sep 29, 2005	Substantially Equivalent	Wrightmedicaltechnologyinc
K043547	COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM	Aug 05, 2005	Substantially Equivalent	Biomet, Inc.
K040627	DEPUY ASR MODULAR ACETABULAR CUP SYSTEM	Aug 05, 2005	Substantially Equivalent	DePuy Orthopaedics, Inc.
K050251	BALANCE HIP SYSTEM	May 27, 2005	Substantially Equivalent	Biomet, Inc.
K043073	PROCOTYL-E ACETABULAR SYSTEM	May 04, 2005	Substantially Equivalent	Wrightmedicaltechnologyinc
K042530	CONSERVE PLUS HA ACETABULAR SHELLS	Dec 17, 2004	Substantially Equivalent	Wrightmedicaltechnologyinc
K040354	METAL/METAL HIP SYSTEM	Nov 04, 2004	Substantially Equivalent	Encore Medical L.P.
K033943	ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED	Oct 18, 2004	Substantially Equivalent	Centerpulse Orthopedics, Inc.
K042037	M2A MAGNUM SYSTEM	Oct 01, 2004	Substantially Equivalent	Biomet, Inc.
K033634	EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED	Sep 15, 2004	Substantially Equivalent	Centerpulse Orthopedics, Inc.
K041425	CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL	Jun 25, 2004	Substantially Equivalent	Wrightmedicaltechnologyinc
K031963	CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD	Oct 31, 2003	Substantially Equivalent	Wrightmedicaltechnologyinc
K023786	DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER	Dec 10, 2002	Substantially Equivalent	DePuy Orthopaedics, Inc.
K021349	METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)	Jul 01, 2002	Substantially Equivalent	Wrightmedicaltechnologyinc
K011110	M2A ACETABULAR SYSTEM	Jul 02, 2001	Substantially Equivalent	Biomet, Inc.
K003758	ALLOFIT ACETABULAR SYSTEM	Mar 07, 2001	Substantially Equivalent	Sulzer Orthopedics, Inc.
K003250	FMP METAL/METAL ACETABULAR INSERT	Jan 25, 2001	Substantially Equivalent	Encore Orthopedics, Inc.
K003523	DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS	Dec 13, 2000	Substantially Equivalent	DePuy Orthopaedics, Inc.
K002883	PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS	Oct 13, 2000	Substantially Equivalent	DePuy Orthopaedics, Inc.
K002379	M2A 28MM RINGLOC LINER	Aug 31, 2000	Substantially Equivalent	Biomet, Inc.
K001523	ULTIMA METAL-ON-METAL ACETABULAR CUP	Aug 10, 2000	Substantially Equivalent	DePuy Orthopaedics, Inc.
K001536	INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS	Jul 27, 2000	Substantially Equivalent	Sulzer Orthopedics, Inc.
K993438	METAL ON METAL ACETABULAR SYSTEM	May 18, 2000	Substantially Equivalent	Biomet, Inc.
K993569	APR METASUL ACETABULAR INSERT	Dec 01, 1999	Substantially Equivalent	Sulzermedica
K974728	INTER-OP METASUL ACETABULAR SYSTEM	Aug 03, 1999	Substantially Equivalent	Sulzer Orthopedics, Inc.
K922868	THOMPSON TYPE HIP PROTHESIS	Feb 12, 1993	Substantially Equivalent	Osteo Technology, Inc.
K902111	MODIFIED FREEMAN REVISION ACETABULAR CUP	Aug 22, 1990	Substantially Equivalent	Turnkey Intergration USA, Inc.
K902110	MODIFIED FREEMAN ACETABULAR CUP	Aug 22, 1990	Substantially Equivalent	Turnkey Intergration USA, Inc.
K901626	H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED	Aug 14, 1990	Substantially Equivalent	Med-Tek Corp.
K895157	S.A.F. ACETABULAR CUP	Dec 01, 1989	Substantially Equivalent	Synergy Orthopaedics Intl., Inc.
K885049	RS-CUP ACETABULAR PROSTHESIS	Jan 13, 1989	Substantially Equivalent	Allo Pro Corp.
K882671	SAMUELSON SCREWLOC CUP	Oct 20, 1988	Substantially Equivalent	Protek, Inc.
K882675	ATH METAL:UHMWPE TOTAL HIP SYSTEM	Aug 19, 1988	Substantially Equivalent for Some Indications	Kinamed, Inc.
K872768	OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.	Jan 14, 1988	Substantially Equivalent	Osteonics Corp.
K872985	SAMUELSON ACETABULAR CUP	Oct 01, 1987	Substantially Equivalent	Protek, Inc.
K870924	CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.	Sep 14, 1987	Substantially Equivalent	Protek, Inc.
K870923	SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.	Sep 14, 1987	Substantially Equivalent	Protek, Inc.
K871453	ZWEYMUELLER-SL HIP PROSTHESIS STEM	Jul 13, 1987	Substantially Equivalent	Allo Pro Corp.
K871956	MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT	Jun 23, 1987	Substantially Equivalent	Downs Surgical , Ltd.
K864515	RING UPM TOTAL HIP REPLACEMENT	Mar 13, 1987	Substantially Equivalent	Downs Surgical , Ltd.
K861723	(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT	Jun 09, 1986	Substantially Equivalent	Osteonics Corp.
K852699	FREEMAN ACETABULAR CUP	Sep 05, 1985	Substantially Equivalent	Advanced Biosearch Assn.
K852351	KIRSCHNER SELF-TAPPING ACETABULAR CUP	Aug 09, 1985	Substantially Equivalent	Kirschner Medical Corp.
K850840	HOWMEDICA THREADED ACETABULAR COMPONENT	Jul 15, 1985	Substantially Equivalent	Pfizer, Inc.
K851404	OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES	Jun 18, 1985	Substantially Equivalent	Osteonics Corp.
K843950	LINK CEMENTLESS SCREW-IN ACETABULAR CUP	Jun 03, 1985	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K843940	LINK CEMENTLESS SCREW-IN ACETABULAR CUP	Jun 03, 1985	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K851213	ZWEYMULLER CUP	May 28, 1985	Substantially Equivalent	Allo Pro Corp.
K850773	PM CEMENTLESS SCREW-IN ACETABULAR CUP	May 02, 1985	Substantially Equivalent	Advanced Biosearch Assn.
K850766	ZIMMER THREADED ACETABULAR CUP	May 01, 1985	Substantially Equivalent	Zimmer, Inc.
K850055	PROFILE FEMORAL HIP	Apr 23, 1985	Substantially Equivalent	Depuy, Inc.
K844943	WEILL CEMENTLESS THREADED ACETABULAR CUP	Mar 18, 1985	Substantially Equivalent	Advanced Biosearch Assn.
K842518	UNILOC-CEMENTLESS & SELF TAP ACETABULAR	Jan 30, 1985	Substantially Equivalent	American Ortomed Corp.
K842466	TITANIUM MITTELMEIER TYPE ACETABULAR	Jan 30, 1985	Substantially Equivalent	American Ortomed Corp.
K780330	TOTAL HIP, LORD MADREPORIC	May 12, 1978	Substantially Equivalent	Howmedica Corp.