Product Code: JDG FDA class 2 21 CFR 888.3360

Prosthesis, Hip, Femoral Component, Cemented, Metal

Orthopedic

A metal cemented femoral component hip prosthesis is an implantable orthopedic device that replaces the femoral head and neck and is fixed within the femoral canal using bone cement, used in total or hemi hip arthroplasty to restore hip joint function in patients with degenerative or traumatic hip disease. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JDG, regulated under 21 CFR 888.3360, within the Orthopedic medical specialty. This device is an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JDG
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 59 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K212431	Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve	Feb 07, 2022	Substantially Equivalent	Biomet, Inc.
K193546	Distal Centralizers	Sep 25, 2020	Substantially Equivalent	Biomet, Inc.
K173499	Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads	Mar 19, 2018	Substantially Equivalent	Stryker Orthopaedics
K001984	PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT	Sep 27, 2000	Substantially Equivalent	Stelkast Company
K992234	THE TAPER-FIT TOTAL HIP SYSTEM	Nov 10, 1999	Substantially Equivalent	Corin USA
K962002	AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM	Aug 08, 1996	Substantially Equivalent	Exactech, Inc.
K955171	NEXLOCK FEMORAL STEM	Feb 09, 1996	Substantially Equivalent	Nexmed, Inc.
K953653	LUBINUS SP II HIP SYSTEM	Nov 06, 1995	Substantially Equivalent	Turnkey Intergration USA, Inc.
K953067	HIP FRACTURE STEM FENESTRATION PLUG	Aug 21, 1995	Substantially Equivalent	Howmedica Corp.
K945783	ORTHOMET TITANIUM HYBRID FEMORAL STEM	May 30, 1995	Substantially Equivalent	Orthomet, Inc.
K951083	PROFORM CEMENTED FEMORAL COMPONENT	May 22, 1995	Substantially Equivalent for Some Indications	Stelkast Company
K942479	INTEGRAL CO-CR FEMORAL COMPONENT	Sep 20, 1994	Substantially Equivalent	Biomet, Inc.
K942028	RX90 FEMORAL COMPONENT	Sep 19, 1994	Substantially Equivalent for Some Indications	Biomet, Inc.
K942027	IMPACT CO-CR 1-PIECE FEMORAL COMPONENT	Sep 19, 1994	Substantially Equivalent for Some Indications	Biomet, Inc.
K931194	CO-CR ANSWER FEMORAL COMPONENT	May 05, 1994	Substantially Equivalent	Biomet, Inc.
K935078	S-ROM TOTAL HIP REPLACEMENT SYSTEM	Mar 09, 1994	Substantially Equivalent for Some Indications	Joint Medical Products Corp.
K933871	BRIDGE(TM) HIP SYSTEM	Feb 23, 1994	Substantially Equivalent for Some Indications	Wrightmedicaltechnologyinc
K915385	PPC HIP STEM COMPONENT	May 17, 1993	Substantially Equivalent for Some Indications	Implantology Corp.
K924099	UFC HIP STEM COMPONENT	Apr 30, 1993	Substantially Equivalent	Implantology Corp.
K915391	FPC HIP STEM COMPONENT	Apr 30, 1993	Substantially Equivalent	Implantology Corp.
K915787	STABILITY HIP STEM WITH POROCOAT	Apr 29, 1993	Substantially Equivalent	Depuy, Inc.
K922682	AMERICANA HIP PROTHESIS	Mar 16, 1993	Substantially Equivalent	Osteo Technology, Inc.
K911595	INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE	Jul 12, 1991	Substantially Equivalent for Some Indications	Dow Corning Wright
K874868	OPTI-FIX COLLARED FEMORAL COMPONENTS	Jan 26, 1988	Substantially Equivalent for Some Indications	Richards Medical Co., Inc.
K874575	PROXIMAL FEMORAL REPLACEMENT PROSTHESIS	Jan 07, 1988	Substantially Equivalent	Dow Corning Wright
K874100	AML CALCAR FEMORAL PROSTHESIS	Dec 31, 1987	Substantially Equivalent for Some Indications	Depuy, Inc.
K873627	CTI STRAIGHT STEM	Dec 30, 1987	Substantially Equivalent	Orthopedic Systems, Inc.
K874740	WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO	Dec 18, 1987	Substantially Equivalent for Some Indications	Dow Corning Wright
K874617	THOMPSON HIP PROSTHESIS	Dec 10, 1987	Substantially Equivalent	Orthopedic Systems, Inc.
K873458	HOWMEDICA PCA COLLARED FEMORAL STEM	Sep 23, 1987	Substantially Equivalent for Some Indications	Howmedica Corp.
K873089	PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM	Sep 16, 1987	Substantially Equivalent	Howmedica Corp.
K851566	HOWMEDICA FEMORAL COMPONENT HIP SYS 6259	Jul 30, 1985	Substantially Equivalent	Howmedica Corp.
K833468	BDH UNIVERSAL HIP SYSTEM SURGEON	Dec 27, 1983	Substantially Equivalent	Carbomedics, Inc.
K812687	BRIGHAM II TOTAL HIP SYSTEM	Oct 02, 1981	Substantially Equivalent	Hexcel Medical
K812669	SEATTLE II TOTAL HIP SYSTEM	Oct 02, 1981	Substantially Equivalent	Hexcel Medical
K801006	CHARNLEY DESIGN HIP PROSTHESIS	May 20, 1980	Substantially Equivalent	Colmed, Ltd.
K800051	HEXCEL FEMORAL COMPONENT HIP PROSTHESIS	Jan 28, 1980	Substantially Equivalent	Hexcel Medical
K800050	ANITOMIC TOTAL HIP SYSTEM	Jan 24, 1980	Substantially Equivalent	Hexcel Medical
K792329	BIOPHASE IMPLANT MATERIAL	Jan 23, 1980	Substantially Equivalent	Richard'S Medical Equip., Inc.
K780773	PROSTHESIS, HIP, CATHCART, SCHILLER MOD.	Jun 22, 1978	Substantially Equivalent	Depuy, Inc.
K780497	SPHERISTEM TOTAL HIP PROSTHESIS	Jun 14, 1978	Substantially Equivalent	American Ortomed Corp.
K780357	TITANIUM MULLER TOTAL HIP	Apr 05, 1978	Substantially Equivalent	Biomet, Inc.
K780329	TOTAL HIP, NEW ENGLAND BAPTIST	Mar 17, 1978	Substantially Equivalent	Depuy, Inc.
K772120	TOTAL HIP, CHARNELY TYPE	Dec 20, 1977	Substantially Equivalent	Depuy, Inc.
K770471	KERBOULL-CHARNLEY CUP SPECIAL MODEL	Mar 24, 1977	Substantially Equivalent	Howmedica Corp.
K770473	LAGRANGE LETOURNEL TOTAL HIP FEMORAL	Mar 17, 1977	Substantially Equivalent	Howmedica Corp.
K770219	WATSON-FARRAR TOTAL HIP REPLACEMENT	Feb 17, 1977	Substantially Equivalent	Orthopedic Equipment Co., Inc.
K770184	BI-CENTRIC ENDOPROSTHESES	Feb 08, 1977	Substantially Equivalent	Howmedica Corp.
K770161	MICROFENESTRATED HIP REPLACEMENT COMPON.	Jan 26, 1977	Substantially Equivalent	Medishield, Inc.
K761243	12-9170 SERIES II TOTAL HIP	Dec 16, 1976	Substantially Equivalent	Richardo Manufacturing Co.
K761146	SPARBARO TYPE TOTAL HIP	Dec 16, 1976	Substantially Equivalent	Orthopedic Equipment Co., Inc.
K761003	CHARNLEY CONGENITAL HIP FEMUR (85-3061)	Nov 23, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.
K761002	CHARNLEY CONGENITAL HIP FEMUR (85-3060)	Nov 23, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.
K760976	CHARNLEY REVISION SET	Nov 16, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.
K760974	CHARNLEY FEMORAL COMPONENT	Nov 16, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.
K760651	TOTAL HIP REPLACEMENT,LAGRANGE-LETOURNEL	Oct 05, 1976	Substantially Equivalent	Orthopedic Equipment Co., Inc.
K760108	PROSTHESIS, TOTAL HIP-TEST CUP	Jul 20, 1976	Substantially Equivalent	Orthopedic Equipment Co., Inc.
K760107	PROSTHESIS, TOTAL HIP-TEST FEMORAL	Jul 20, 1976	Substantially Equivalent	Orthopedic Equipment Co., Inc.
K760106	PROSTHESIS, TOTAL HIP-FEMORAL	Jul 20, 1976	Substantially Equivalent	Orthopedic Equipment Co., Inc.