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

Zimmer Trabecular Metal Technology — Predicate Candidate Screening

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

111 daysmedian FDA review time
180 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K133784VISTA-S DEVICE, ASSOCIATED INSTRUMENTATIONZimmer Trabecular Metal Technology2014-07-072070
K123602TM ARDIS INTERBODY SYSTEM INSERTERZimmer Trabecular Metal Technology2013-03-011000
K120990NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVIZimmer Trabecular Metal Technology2012-06-29880
K113561TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMEZimmer Trabecular Metal Technology2012-05-291801
K111983VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXXZimmer Trabecular Metal Technology2011-11-181290
K103033TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXZimmer Trabecular Metal Technology2011-01-10890
K102896TRABECULAR METAL TIBIAL CONE AUGMENTSZimmer Trabecular Metal Technology2010-12-13740
K093127TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEZimmer Trabecular Metal Technology2010-03-041530
K070754TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06Zimmer Trabecular Metal Technology2007-08-311650
K071090TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTIONZimmer Trabecular Metal Technology2007-06-29720
K070382VISTA -S DEVICEZimmer Trabecular Metal Technology2007-05-301110

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