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

Zimmer Trabecular — Predicate Candidate Screening

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

62 daysmedian FDA review time

149 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061155	VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM	Zimmer Trabecular	2006-09-22	149	0
K061067	TRABECULAR METAL ACETABULAR AUGMENTS	Zimmer Trabecular	2006-05-25	38	4
K053340	TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS	Zimmer Trabecular	2006-02-27	88	0
K052950	THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT S	Zimmer Trabecular	2005-11-16	27	0
K051756	MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODE	Zimmer Trabecular	2005-07-27	28	0
K050766	EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM	Zimmer Trabecular	2005-05-26	62	0
K050937	TRABECULAR METAL ACETABULAR REVISION SHELLS	Zimmer Trabecular	2005-05-11	27	0
K050101	THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11	Zimmer Trabecular	2005-04-15	87	0
K042871	TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02	Zimmer Trabecular	2004-12-21	64	0
K043061	THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE	Zimmer Trabecular	2004-11-23	18	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