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

JDL — Predicate Candidate Screening

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

92 daysmedian FDA review time

413 days90th percentile

45clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K073499	VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES	Zimmer, Inc.	2008-08-07	238	0
K070785	DYNASTY ACETABULAR SYSTEM	Wrightmedicaltechnologyinc	2007-07-11	112	0
K061844	DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER	Wrightmedicaltechnologyinc	2006-12-06	160	0
K051995	PROFEMUR RENAISSANCE HIP STEM	Wrightmedicaltechnologyinc	2005-08-22	28	0
K051348	CONSERVE TOTAL FEMORAL HEAD	Wrightmedicaltechnologyinc	2005-08-19	87	0
K042841	M2A/C2A ACETABULAR SYSTEM	Biomet, Inc.	2004-12-21	68	0
K041586	PROFEMUR S HIP STEM	Wrightmedicaltechnologyinc	2004-07-09	25	0
K041114	PROFEMUR TAPERED HIP STEM	Wrightmedicaltechnologyinc	2004-05-28	30	0
K004043	METAL TRANSCEND ARTICULATION SYSTEM	Wrightmedicaltechnologyinc	2001-07-13	196	0
K950542	METAL BACKED ACETABULAR COMPONENT	Encore Orthopedics, Inc.	1995-05-25	107	1
K944769	P.F.C. APICAL PLUG	Johnson & Johnson Professionals, Inc.	1994-12-08	72	0
K942809	ACETABULAR DOME HOLE PLUGS	Osteonics Corp.	1994-09-20	98	0
K931676	S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG	Joint Medical Products Corp.	1994-05-18	407	0
K930833	PCA(R) SOLID BACK ACETABULA SHELL	Howmedica Corp.	1994-02-22	370	0
K934440	PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES	Howmedica Corp.	1994-02-22	231	0
K935669	SYRIGENE PRE-FILLED SYRINGE	Regulatory & Marketing Services, Inc.	1994-02-18	84	0
K922561	CONSENSUS(TM) TOTAL HIP SYSTEM	U.S. Medical Products, Inc.	1993-07-21	413	0
K915529	FPC/SFPC/RFPC ACETABULAR COMPONENT	Implantology Corp.	1993-07-13	581	0
K915527	CPS ACETABULAR COMPONENT	Implantology Corp.	1993-06-24	562	0
K922861	BIOMETRIC SCREW FIXATION CUP	Osteo Technology, Inc.	1993-05-12	342	0
K920929	POLY INSERT 20 DEGREE	Dow Corning Wright	1993-05-05	432	0
K925181	TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP	Techmedica, Inc.	1993-02-05	114	0
K921139	HEALEY REVISION COMPONENT SYSTEM	Biomet, Inc.	1992-07-01	113	0
K921384	PCA ACETABULAR INSERT II	Howmedica Corp.	1992-06-25	94	0
K920868	ACETABULAR DOME AND SCREW HOLE PLUGS	Osteonics Corp.	1992-05-26	90	0
K896614	S.A.F. ACETABULAR CUP WITH POROUS COATING	Synergy Orthopaedics Intl., Inc.	1990-01-09	49	0
K894965	POROUS-COATED TITANIUM ACETABULAR CUP	Dow Corning Wright	1989-11-17	102	0
K895607	POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT	Exactech, Inc.	1989-11-17	60	0
K892640	PNEUMOTHORAX KIT, MOTIFICATION	Arrow Intl., Inc.	1989-10-11	182	0
K870867	KM-4(TM) METAL-BACKED ACETABULAR CUP	Kirschner Medical Corp.	1987-05-08	66	0
K870234	P.T.H. METAL-BACKED ACETABULAR CUP	Orthopaedic Device Corp.	1987-03-20	58	0
K861264	JOINT MEASUREMENT INDICATOR	Devcom, Inc.	1986-04-15	11	0
K855042	KM-3 ACETABULAR COMPONENT	Kirschner Medical Corp.	1986-03-14	87	0
K854107	DIMENSION TOTAL HIP PROSTHESIS POROUS COATED	Kirschner Medical Corp.	1986-03-10	153	0
K854935	LINK METAL-BACKED ACETABULAR CUPS	Link America, Inc.	1986-03-05	85	0
K852369	LIDGRER-LUND ACETABULAR SOCKETS	Link America, Inc.	1985-06-18	14	0
K850793	MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA	Intermedics Orthopedics	1985-05-09	72	0
K850352	MICRO-STRUC. ACETABULAR COMPON- MC2P	Osteonics Corp.	1985-04-25	87	0
K844482	MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT	Advanced Biosearch Assn.	1985-02-19	92	0
K842893	DORR HIP PROSTHESIS, ACETABULAR COMPON	Carbomedics, Inc.	1984-11-08	108	0
K831792	SELF-ALIGNING ACETABULAR COMPONENT	Endomedics, Inc.	1984-09-20	475	0
K830662	NATURAL LOCK ACETABULAR COMPONENT	Advanced Biosearch Assn.	1983-04-11	39	0
K813599	101-32 FEMORAL COMPONENT	Intermedics Orthopedics	1982-01-22	25	0
K790274	BG PROXIMAL FEMUR	Howmedica Corp.	1979-03-26	46	0
K770472	PROSTHESIS, VIDAL TOTAL HIP	Howmedica Corp.	1977-03-17	7	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