Atlas FDA

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

4Web, Inc. — Predicate Candidate Screening

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

138 daysmedian FDA review time
192 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.2026-02-121390
K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.2021-03-101520
K200002Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbod4Web, Inc.2020-05-291480
K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.2019-08-121310
K190926Hammertoe Truss System (HTS)4Web, Inc.2019-07-231050
K172294Osteotomy Truss System (OTS)4Web, Inc.2018-02-222060
K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.2018-01-081010
K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.2017-11-07910
K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.2017-09-081220
K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.2017-08-071380
K153436LATERAL Spine Truss System4Web, Inc.2016-06-061920
K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015-04-091470
K1421124WEB SPINAL IMPLANT PRODUCTS4Web, Inc.2014-09-23500

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