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

Implex Corp. — Predicate Candidate Screening

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

81 daysmedian FDA review time

312 days90th percentile

65clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K051978	TRABECULAR METAL VERTEBRAL BODY REPLACEMENT	Implex Corp.	2005-09-23	64	0
K051196	TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-01	Implex Corp.	2005-06-17	38	0
K040487	TRABECULAR METAL KNEE SYSTEM AUGMENTS	Implex Corp.	2004-12-21	300	1
K040630	TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ	Implex Corp.	2004-09-30	204	2
K040756	THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXX	Implex Corp.	2004-07-14	112	0
K031962	NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS	Implex Corp.	2004-01-08	197	0
K033384	THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 0	Implex Corp.	2003-11-19	27	0
K032527	HEDROCEL VERTEBRAL BODY REPLACEMENT	Implex Corp.	2003-10-31	77	0
K032344	THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10	Implex Corp.	2003-10-02	64	0
K031449	MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLAT	Implex Corp.	2003-09-23	139	8
K032282	MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYS	Implex Corp.	2003-08-21	28	0
K031462	THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS	Implex Corp.	2003-08-06	90	0
K031823	HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1	Implex Corp.	2003-07-11	28	0
K023882	THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM	Implex Corp.	2003-02-19	90	0
K024161	NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS	Implex Corp.	2003-01-15	29	0
K022377	THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SH	Implex Corp.	2002-12-10	141	8
K022966	PROXILOCK HIP PROSTHESIS; SIZE 12/36	Implex Corp.	2002-10-02	26	0
K022563	HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1	Implex Corp.	2002-08-30	28	0
K021967	HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND	Implex Corp.	2002-07-17	30	0
K021970	THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (Z	Implex Corp.	2002-07-12	25	0
K021025	MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL X	Implex Corp.	2002-05-20	52	0
K020295	NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00	Implex Corp.	2002-02-12	15	1
K010378	HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ	Implex Corp.	2002-01-28	354	0
K012866	THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0	Implex Corp.	2001-09-26	30	1
K012507	THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, M	Implex Corp.	2001-08-30	24	0
K012095	THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (Z	Implex Corp.	2001-07-26	21	0
K011904	NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-	Implex Corp.	2001-07-19	30	0
K004013	IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-X	Implex Corp.	2001-01-25	29	0
K003181	IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX	Implex Corp.	2000-11-07	27	0
K001759	HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ	Implex Corp.	2000-08-24	76	0
K001471	THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ	Implex Corp.	2000-08-07	88	0
K001039	THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP	Implex Corp.	2000-06-15	76	0
K001307	CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL X	Implex Corp.	2000-05-23	29	0
K990330	CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-	Implex Corp.	2000-03-01	393	0
K994076	IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIO	Implex Corp.	2000-02-18	78	0
K992409	THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL X	Implex Corp.	1999-10-08	80	0
K991869	COBREX HIP STEM, MODEL 01-128-XXXXX	Implex Corp.	1999-07-14	43	0
K983837	HEDROCEL ACETABULAR CAGE SYSTEM	Implex Corp.	1999-07-01	244	0
K990183	IMPLEX ALUMINA FEMORAL HEAD	Implex Corp.	1999-06-11	142	0
K984290	IMPLEX RADIAL HEAD REPLACEMENT SYSTEM	Implex Corp.	1999-06-01	182	0
K983835	IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA	Implex Corp.	1999-03-15	136	0
K984291	CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT	Implex Corp.	1999-02-01	62	0
K982751	IMPLEX SCREW AND WASHER SYSTEM	Implex Corp.	1999-02-01	179	0
K980637	IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT	Implex Corp.	1998-12-16	300	0
K983128	IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-	Implex Corp.	1998-12-03	86	0
K982302	IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS	Implex Corp.	1998-07-31	30	0
K981560	IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL	Implex Corp.	1998-06-08	38	0
K980781	IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS	Implex Corp.	1998-05-22	81	0
K980486	IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS M	Implex Corp.	1998-04-14	64	0
K971705	IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED	Implex Corp.	1997-08-06	90	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