Product Code: JDL FDA class 3 21 CFR 888.3320

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

Orthopedic

A semi-constrained metal cemented acetabular component hip prosthesis is an implantable device that replaces the acetabular socket in total hip arthroplasty, fixed to the pelvis with bone cement, providing partial constraint to the articulation while allowing controlled hip motion. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) demonstrating safety and effectiveness prior to marketing. The product code is JDL, regulated under 21 CFR 888.3320, within the Orthopedic medical specialty. This device is an implant.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: JDL
Device Class: FDA class 3
Regulation Number: 888.3320
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 45 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K073499	VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES	Aug 07, 2008	Substantially Equivalent	Zimmer, Inc.
K070785	DYNASTY ACETABULAR SYSTEM	Jul 11, 2007	Substantially Equivalent	Wrightmedicaltechnologyinc
K061844	DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER	Dec 06, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K051995	PROFEMUR RENAISSANCE HIP STEM	Aug 22, 2005	Substantially Equivalent	Wrightmedicaltechnologyinc
K051348	CONSERVE TOTAL FEMORAL HEAD	Aug 19, 2005	Substantially Equivalent	Wrightmedicaltechnologyinc
K042841	M2A/C2A ACETABULAR SYSTEM	Dec 21, 2004	Substantially Equivalent	Biomet, Inc.
K041586	PROFEMUR S HIP STEM	Jul 09, 2004	Substantially Equivalent	Wrightmedicaltechnologyinc
K041114	PROFEMUR TAPERED HIP STEM	May 28, 2004	Substantially Equivalent	Wrightmedicaltechnologyinc
K004043	METAL TRANSCEND ARTICULATION SYSTEM	Jul 13, 2001	Substantially Equivalent	Wrightmedicaltechnologyinc
K950542	METAL BACKED ACETABULAR COMPONENT	May 25, 1995	Substantially Equivalent	Encore Orthopedics, Inc.
K944769	P.F.C. APICAL PLUG	Dec 08, 1994	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K942809	ACETABULAR DOME HOLE PLUGS	Sep 20, 1994	Substantially Equivalent	Osteonics Corp.
K931676	S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG	May 18, 1994	Substantially Equivalent	Joint Medical Products Corp.
K934440	PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES	Feb 22, 1994	Substantially Equivalent	Howmedica Corp.
K930833	PCA(R) SOLID BACK ACETABULA SHELL	Feb 22, 1994	Substantially Equivalent	Howmedica Corp.
K935669	SYRIGENE PRE-FILLED SYRINGE	Feb 18, 1994	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K922561	CONSENSUS(TM) TOTAL HIP SYSTEM	Jul 21, 1993	Substantially Equivalent	U.S. Medical Products, Inc.
K915529	FPC/SFPC/RFPC ACETABULAR COMPONENT	Jul 13, 1993	Substantially Equivalent	Implantology Corp.
K915527	CPS ACETABULAR COMPONENT	Jun 24, 1993	Substantially Equivalent	Implantology Corp.
K922861	BIOMETRIC SCREW FIXATION CUP	May 12, 1993	Substantially Equivalent	Osteo Technology, Inc.
K920929	POLY INSERT 20 DEGREE	May 05, 1993	Substantially Equivalent	Dow Corning Wright
K925181	TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP	Feb 05, 1993	Substantially Equivalent	Techmedica, Inc.
K921139	HEALEY REVISION COMPONENT SYSTEM	Jul 01, 1992	Substantially Equivalent	Biomet, Inc.
K921384	PCA ACETABULAR INSERT II	Jun 25, 1992	Substantially Equivalent	Howmedica Corp.
K920868	ACETABULAR DOME AND SCREW HOLE PLUGS	May 26, 1992	Substantially Equivalent	Osteonics Corp.
K896614	S.A.F. ACETABULAR CUP WITH POROUS COATING	Jan 09, 1990	Substantially Equivalent for Some Indications	Synergy Orthopaedics Intl., Inc.
K895607	POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT	Nov 17, 1989	Substantially Equivalent for Some Indications	Exactech, Inc.
K894965	POROUS-COATED TITANIUM ACETABULAR CUP	Nov 17, 1989	Substantially Equivalent for Some Indications	Dow Corning Wright
K892640	PNEUMOTHORAX KIT, MOTIFICATION	Oct 11, 1989	Substantially Equivalent	Arrow Intl., Inc.
K870867	KM-4(TM) METAL-BACKED ACETABULAR CUP	May 08, 1987	Substantially Equivalent	Kirschner Medical Corp.
K870234	P.T.H. METAL-BACKED ACETABULAR CUP	Mar 20, 1987	Substantially Equivalent	Orthopaedic Device Corp.
K861264	JOINT MEASUREMENT INDICATOR	Apr 15, 1986	Substantially Equivalent	Devcom, Inc.
K855042	KM-3 ACETABULAR COMPONENT	Mar 14, 1986	Substantially Equivalent for Some Indications	Kirschner Medical Corp.
K854107	DIMENSION TOTAL HIP PROSTHESIS POROUS COATED	Mar 10, 1986	Substantially Equivalent for Some Indications	Kirschner Medical Corp.
K854935	LINK METAL-BACKED ACETABULAR CUPS	Mar 05, 1986	Substantially Equivalent	Link America, Inc.
K852369	LIDGRER-LUND ACETABULAR SOCKETS	Jun 18, 1985	Substantially Equivalent	Link America, Inc.
K850793	MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA	May 09, 1985	Substantially Equivalent	Intermedics Orthopedics
K850352	MICRO-STRUC. ACETABULAR COMPON- MC2P	Apr 25, 1985	Substantially Equivalent	Osteonics Corp.
K844482	MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT	Feb 19, 1985	Substantially Equivalent	Advanced Biosearch Assn.
K842893	DORR HIP PROSTHESIS, ACETABULAR COMPON	Nov 08, 1984	Substantially Equivalent	Carbomedics, Inc.
K831792	SELF-ALIGNING ACETABULAR COMPONENT	Sep 20, 1984	Substantially Equivalent	Endomedics, Inc.
K830662	NATURAL LOCK ACETABULAR COMPONENT	Apr 11, 1983	Substantially Equivalent	Advanced Biosearch Assn.
K813599	101-32 FEMORAL COMPONENT	Jan 22, 1982	Substantially Equivalent	Intermedics Orthopedics
K790274	BG PROXIMAL FEMUR	Mar 26, 1979	Substantially Equivalent	Howmedica Corp.
K770472	PROSTHESIS, VIDAL TOTAL HIP	Mar 17, 1977	Substantially Equivalent	Howmedica Corp.