510(k) Report

FDA applicant

International Life Sciences

Marietta, GA4 decisions2019–20263 recalls

FDA records 4 decisions for International Life Sciences (Marietta, GA) from 2019 to 2026: 4 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and FTL (Mesh, Surgical, Polymeric). Its devices cite 7 predicates, 3 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided International Life Sciences’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019: 12020: 12023: 12026 (partial year): 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

3in 2026

2026 (partial year): 3
2019high 3 (2026) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — International Life Sciences by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision
  • FTLMesh, Surgical, Polymeric1decision
  • OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon1decision
  • QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament1decision

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 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.

  • K192112FlexBand PlusInternational Life Sciences · 20193cite it
  • K200503ATL AnchorsInternational Life Sciences · 20202cite it
  • K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 20232cite it

What has FDA decided for it lately?

  • K260317Artelon Convenience KitsInternational Life Sciences · 2026
  • K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 20233 recalls
  • K200503ATL AnchorsInternational Life Sciences · 20202 recalls
  • K192112FlexBand PlusInternational Life Sciences · 2019

All 4 as International Life Sciences →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K230316Artelon FlexBand Plus Ref: 41054 & 41057Feb 6, 2026Class II
  • K200503Artelon FlexBand Dynamic Matrix Ref: 31057Feb 6, 2026Class II
  • K200503Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor…Feb 6, 2026Class II