Atlas FDA

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

Vilex, Inc. — Predicate Candidate Screening

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

103 daysmedian FDA review time
447 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K132820VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS ANVilex, Inc.2014-07-233170
K112837VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)Vilex, Inc.2012-10-093770
K102413FUZE: INTRAMEDULLARY INTERNAL FIXATION NAILVilex, Inc.2011-11-144473
K102401HEMI IMPLANT; MINI HEMI IMPLANTVilex, Inc.2011-07-203300
K070052MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATIONVilex, Inc.2007-03-28830
K052196VILEX X-FIXVilex, Inc.2005-11-221030
K041289TALUS OF VILEX (TOV)Vilex, Inc.2004-08-05840
K041287VILEX BONE PLATE SYSTEMVilex, Inc.2004-08-05840
K023684CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ2Vilex, Inc.2004-03-014860
K014154VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL FVilex, Inc.2002-03-18900
K991151VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORVilex, Inc.1999-04-26200
K991197VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S2Vilex, Inc.1999-04-26190
K973309VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREWVilex, Inc.1998-01-161350

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