510(k) Report

FDA applicant

Arthocare Corporation

Austin, TX6 decisions2001–20161 recall

FDA records 6 decisions for Arthocare Corporation (Austin, TX) from 2001 to 2016: 6 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). Its devices cite 8 predicates, 0 of them its own earlier devices. 1 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 Arthocare Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 32013: 12016: 1
2007high 3 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Arthocare Corporation’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?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue3decisions
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K120791Ambient Turboflash 90 IfsArthocare Corporation · 20122cite it
  • K131182Multifix S Knotless Fixation DeviceArthocare Corporation · 20132cite it
  • K121306Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device HandleArthocare Corporation · 20121cites it

What has FDA decided for it lately?

  • K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation · 2016
  • K131182Multifix S Knotless Fixation DeviceArthocare Corporation · 2013
  • K120791Ambient Turboflash 90 IfsArthocare Corporation · 2012
  • K123268Smartstitch Perfectpasser SystemArthocare Corporation · 20121 recall
  • K121306Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device HandleArthocare Corporation · 2012
  • K013334EndoflipArthocare Corporation · 2001

All 6 as Arthocare Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K123268Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI…Feb 21, 2019Class II