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

Depuy, Inc. — Predicate Candidate Screening

303 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

80 daysmedian FDA review time

227 days90th percentile

303clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K043058	PINNACLE CONSTRAINED ACETABULAR LINERS	Depuy, Inc.	2005-03-14	129	0
K042664	LPS UPPER EXTREMITY	Depuy, Inc.	2004-12-08	71	0
K041085	LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTE	Depuy, Inc.	2004-07-22	87	1
K033959	LPS	Depuy, Inc.	2004-07-01	192	0
K040544	DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO	Depuy, Inc.	2004-05-28	87	0
K021478	DELTA SHOULDER	Depuy, Inc.	2003-11-18	559	0
K033329	DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS	Depuy, Inc.	2003-11-14	29	0
K032151	DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS	Depuy, Inc.	2003-09-26	74	12
K020541	AGILITY ANKLE REVISION PROSTHESIS	Depuy, Inc.	2002-05-20	90	0
K011810	ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESI	Depuy, Inc.	2001-09-07	88	0
K003182	ORTHOGENESIS LPS SYSTEM	Depuy, Inc.	2001-06-27	259	0
K001922	DEPUY NEUFLEX PIP FINGER	Depuy, Inc.	2000-08-29	67	0
K993465	DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE	Depuy, Inc.	2000-01-11	90	0
K991649	DEPUY ROCKWOOD CLAVICLE PIN	Depuy, Inc.	1999-07-14	62	0
K991135	SOFT TISSUE SUTURE WASHER	Depuy, Inc.	1999-04-29	24	0
K984158	P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY	Depuy, Inc.	1999-01-28	70	0
K984378	DEPUY ACROMED MOSS SPINAL SYSTEM	Depuy, Inc.	1998-12-30	23	0
K983583	DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS	Depuy, Inc.	1998-12-03	51	0
K982330	DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT	Depuy, Inc.	1998-09-25	85	0
K982320	DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM	Depuy, Inc.	1998-09-14	74	0
K982511	DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS	Depuy, Inc.	1998-09-14	56	0
K982900	PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW	Depuy, Inc.	1998-08-31	14	0
K981670	DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTO	Depuy, Inc.	1998-06-22	41	0
K980794	DUAL LOCK HIP STEM	Depuy, Inc.	1998-05-20	79	0
K980368	DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM	Depuy, Inc.	1998-04-14	74	0
K980440	DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE	Depuy, Inc.	1998-04-03	58	0
K974740	DEPUY TRI-LOCK HIP STEM	Depuy, Inc.	1998-03-18	89	0
K974781	DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL	Depuy, Inc.	1998-03-10	78	0
K974573	DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM	Depuy, Inc.	1998-02-18	72	0
K972643	DEPUY AMK 3 PEG PATELLA	Depuy, Inc.	1998-01-21	190	0
K972596	DEPUY DURALOC ACETABULAR CUP SYSTEM	Depuy, Inc.	1997-11-12	124	0
K973060	DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM	Depuy, Inc.	1997-11-03	77	0
K971730	DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM	Depuy, Inc.	1997-11-03	178	0
K972832	PROVISION SURGICAL HELMET SYSTEM	Depuy, Inc.	1997-10-21	83	3
K972629	DEPUY AE TK2 HIP SCREW SYSTEM	Depuy, Inc.	1997-10-09	87	2
K972494	DEPUY DUPONT ABSORBABLE SET SCREW	Depuy, Inc.	1997-10-01	90	0
K972568	DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM	Depuy, Inc.	1997-09-19	71	0
K970544	DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS	Depuy, Inc.	1997-09-12	212	0
K970241	DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS	Depuy, Inc.	1997-08-14	204	0
K971742	DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT	Depuy, Inc.	1997-07-24	73	0
K964650	TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS	Depuy, Inc.	1997-06-19	211	0
K970929	DEPUY LOW PROFILE BONE SCREW	Depuy, Inc.	1997-06-09	88	0
K964114	DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS	Depuy, Inc.	1997-05-06	203	0
K964024	DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM	Depuy, Inc.	1997-03-26	170	0
K962628	MOSS MIAMI SPINAL SYSTEM	Depuy, Inc.	1997-03-18	256	0
K965145	DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM	Depuy, Inc.	1997-03-13	80	0
K964521	DEPUY DUPONT PHANTOM SUTURE ANCHOR	Depuy, Inc.	1997-02-06	86	0
K964704	DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM	Depuy, Inc.	1997-01-24	60	0
K962486	DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM	Depuy, Inc.	1996-12-27	184	0
K963973	DEPUY CANNULATED CROSS PIN SCREW SYSTEM	Depuy, Inc.	1996-12-16	74	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