4-WEB ALIF SPINAL TRUSS SYSTEM (STS)— 510(k) K112316

Name: FDA 510(k) clearance K112316
Creator: U.S. Food and Drug Administration
Published: 2011-12-14

Substantially Equivalent

4-Web, Inc.

FDA 510(k) clearance K112316 for 4-WEB ALIF SPINAL TRUSS SYSTEM (STS), Substantially Equivalent on 2011-12-14. Applicant: 4-Web, Inc.. Device class: 2.

Clearance details

Applicant: 4-Web, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2011-08-11
Decision date: 2011-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Apple Valley, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

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K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

More clearances from 4-Web, Inc.

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K130185 — 4WEB OSTEOTOMY BONE WEDGE2013-06-07
K121741 — 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)2012-10-18

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K112316

K-number listed on FDA's recall record

Z-0812-2015 — ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm heightClass II·Terminated·4-Web Inc.·20140929

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112316.

Data sourced from openFDA. This site is unofficial and independent of the FDA.