Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

JDG — Predicate Candidate Screening

59 FDA 510(k) clearances under this product code; the 50 most recent screened below.

60 daysmedian FDA review time

280 days90th percentile

59clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K212431	Biomet Answer/Impact/Integral Distal Centralizer/Centering S	Biomet, Inc.	2022-02-07	187	0
K193546	Distal Centralizers	Biomet, Inc.	2020-09-25	280	0
K173499	Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Hea	Stryker Orthopaedics	2018-03-19	126	0
K001984	PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT	Stelkast Company	2000-09-27	90	0
K992234	THE TAPER-FIT TOTAL HIP SYSTEM	Corin USA	1999-11-10	131	0
K962002	AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM	Exactech, Inc.	1996-08-08	78	0
K955171	NEXLOCK FEMORAL STEM	Nexmed, Inc.	1996-02-09	88	0
K953653	LUBINUS SP II HIP SYSTEM	Turnkey Intergration USA, Inc.	1995-11-06	95	5
K953067	HIP FRACTURE STEM FENESTRATION PLUG	Howmedica Corp.	1995-08-21	52	0
K945783	ORTHOMET TITANIUM HYBRID FEMORAL STEM	Orthomet, Inc.	1995-05-30	186	0
K951083	PROFORM CEMENTED FEMORAL COMPONENT	Stelkast Company	1995-05-22	74	0
K942479	INTEGRAL CO-CR FEMORAL COMPONENT	Biomet, Inc.	1994-09-20	118	1
K942027	IMPACT CO-CR 1-PIECE FEMORAL COMPONENT	Biomet, Inc.	1994-09-19	146	0
K942028	RX90 FEMORAL COMPONENT	Biomet, Inc.	1994-09-19	146	0
K931194	CO-CR ANSWER FEMORAL COMPONENT	Biomet, Inc.	1994-05-05	422	0
K935078	S-ROM TOTAL HIP REPLACEMENT SYSTEM	Joint Medical Products Corp.	1994-03-09	135	0
K933871	BRIDGE(TM) HIP SYSTEM	Wrightmedicaltechnologyinc	1994-02-23	198	0
K915385	PPC HIP STEM COMPONENT	Implantology Corp.	1993-05-17	535	0
K915391	FPC HIP STEM COMPONENT	Implantology Corp.	1993-04-30	518	0
K924099	UFC HIP STEM COMPONENT	Implantology Corp.	1993-04-30	260	0
K915787	STABILITY HIP STEM WITH POROCOAT	Depuy, Inc.	1993-04-29	492	0
K922682	AMERICANA HIP PROTHESIS	Osteo Technology, Inc.	1993-03-16	285	0
K911595	INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE	Dow Corning Wright	1991-07-12	94	0
K874868	OPTI-FIX COLLARED FEMORAL COMPONENTS	Richards Medical Co., Inc.	1988-01-26	60	0
K874575	PROXIMAL FEMORAL REPLACEMENT PROSTHESIS	Dow Corning Wright	1988-01-07	62	0
K874100	AML CALCAR FEMORAL PROSTHESIS	Depuy, Inc.	1987-12-31	84	0
K873627	CTI STRAIGHT STEM	Orthopedic Systems, Inc.	1987-12-30	113	0
K874740	WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO	Dow Corning Wright	1987-12-18	30	0
K874617	THOMPSON HIP PROSTHESIS	Orthopedic Systems, Inc.	1987-12-10	31	0
K873458	HOWMEDICA PCA COLLARED FEMORAL STEM	Howmedica Corp.	1987-09-23	26	0
K873089	PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM	Howmedica Corp.	1987-09-16	42	0
K851566	HOWMEDICA FEMORAL COMPONENT HIP SYS 6259	Howmedica Corp.	1985-07-30	105	0
K833468	BDH UNIVERSAL HIP SYSTEM SURGEON	Carbomedics, Inc.	1983-12-27	82	0
K812687	BRIGHAM II TOTAL HIP SYSTEM	Hexcel Medical	1981-10-02	10	0
K812669	SEATTLE II TOTAL HIP SYSTEM	Hexcel Medical	1981-10-02	11	0
K801006	CHARNLEY DESIGN HIP PROSTHESIS	Colmed, Ltd.	1980-05-20	22	0
K800051	HEXCEL FEMORAL COMPONENT HIP PROSTHESIS	Hexcel Medical	1980-01-28	19	0
K800050	ANITOMIC TOTAL HIP SYSTEM	Hexcel Medical	1980-01-24	15	0
K792329	BIOPHASE IMPLANT MATERIAL	Richard'S Medical Equip., Inc.	1980-01-23	65	0
K780773	PROSTHESIS, HIP, CATHCART, SCHILLER MOD.	Depuy, Inc.	1978-06-22	49	0
K780497	SPHERISTEM TOTAL HIP PROSTHESIS	American Ortomed Corp.	1978-06-14	78	0
K780357	TITANIUM MULLER TOTAL HIP	Biomet, Inc.	1978-04-05	30	0
K780329	TOTAL HIP, NEW ENGLAND BAPTIST	Depuy, Inc.	1978-03-17	18	0
K772120	TOTAL HIP, CHARNELY TYPE	Depuy, Inc.	1977-12-20	41	0
K770471	KERBOULL-CHARNLEY CUP SPECIAL MODEL	Howmedica Corp.	1977-03-24	14	0
K770473	LAGRANGE LETOURNEL TOTAL HIP FEMORAL	Howmedica Corp.	1977-03-17	7	0
K770219	WATSON-FARRAR TOTAL HIP REPLACEMENT	Orthopedic Equipment Co., Inc.	1977-02-17	14	0
K770184	BI-CENTRIC ENDOPROSTHESES	Howmedica Corp.	1977-02-08	12	0
K770161	MICROFENESTRATED HIP REPLACEMENT COMPON.	Medishield, Inc.	1977-01-26	2	0
K761146	SPARBARO TYPE TOTAL HIP	Orthopedic Equipment Co., Inc.	1976-12-16	20	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda