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

Vilex IN Tennessee, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time

284 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K191289	Bone Screw Line Addition	Vilex IN Tennessee, Inc.	2019-07-29	77	0
K190543	Cannulated Hemi Implant	Vilex IN Tennessee, Inc.	2019-05-31	88	0
K163487	Ultima HA Coated Half Pins and Wire	Vilex IN Tennessee, Inc.	2017-02-13	63	0
K151881	X-Fix Line Additions	Vilex IN Tennessee, Inc.	2016-03-24	259	1
K150211	EzFuze Implant System	Vilex IN Tennessee, Inc.	2015-11-10	284	0
K151456	Small Bone Nail Implant	Vilex IN Tennessee, Inc.	2015-10-29	150	0
K141937	TRIDENT FUSION IMPLANT	Vilex IN Tennessee, Inc.	2014-09-10	55	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