510(k) Report

FDA applicant

4Web, Inc.

Frisco, TX13 decisions2014–20260 recalls

FDA records 13 decisions for 4Web, Inc. (Frisco, TX) from 2014 to 2026: 13 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 138 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided 4Web, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014: 12015: 12016: 12017: 32018: 22019: 22020: 12021: 12026 (partial year): 1
2014high 3 (2017) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — 4Web, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 4Web, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar6decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions
  • HTYPin, Fixation, Smooth1decision
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Also: HRS (1).

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 138 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 2 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 32 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 40 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K1421124WEB Spinal Implant Products4Web, Inc. · 20146cite it
  • K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 20156cite it
  • K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 20216cite it
  • K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 20194cite it
  • K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 20184cite it
  • K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc. · 20173cite it

What has FDA decided for it lately?

  • K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc. · 2026
  • K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
  • K200002Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device4Web, Inc. · 2020
  • K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 2019
  • K190926Hammertoe Truss System (HTS)4Web, Inc. · 2019
  • K172294Osteotomy Truss System (OTS)4Web, Inc. · 2018
  • K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018
  • K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc. · 2017

All 13 as 4Web, Inc. →

Other applicant names beginning “4Web”

FDA records each applicant name separately; these may or may not be the same firm.

4Web Medical, Inc. 13