510(k) Report

FDA applicant

Artimplant AB

Washington, DC7 decisions2003–20070 recalls

FDA records 7 decisions for Artimplant AB (Washington, DC) from 2003 to 2007: 7 510(k) clearances. Most are in product codes KYI (Prosthesis, Wrist, Carpal Trapezium) and FTL (Mesh, Surgical, Polymeric). Its devices cite 16 predicates, 4 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, general and plastic surgery panel, where it files most

How often FDA has decided Artimplant AB’s devices, and how often a recall has named them.

FDA decisions per year

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Artimplant AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KYIProsthesis, Wrist, Carpal Trapezium3decisions
  • FTLMesh, Surgical, Polymeric2decisions
  • GARSuture, Nonabsorbable, Synthetic, Polyamide2decisions

Whose devices does it build on?

Its devices cite 16 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 4 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.

  • K052830SportmeshArtimplant AB · 20066cite it
  • K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 20076cite it
  • K040070Artelon Spacer CMC-1Artimplant AB · 20042cite it
  • K032160Artelon Surgical SutureArtimplant AB · 20031cites it

What has FDA decided for it lately?

  • K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
  • K061956Artelon STT SpacerArtimplant AB · 2007
  • K061954Artelon CMC Spacer ArthroArtimplant AB · 2007
  • K052830SportmeshArtimplant AB · 2006
  • K052482Artelon Surgical SutureArtimplant AB · 2005
  • K040070Artelon Spacer CMC-1Artimplant AB · 2004
  • K032160Artelon Surgical SutureArtimplant AB · 2003

All 7 as Artimplant AB →