510(k) Report

FDA applicant

Arc Surgical, LLC

Hillsboro, OR5 decisions2005–20151 recall

FDA records 5 decisions for Arc Surgical, LLC (Hillsboro, OR) from 2005 to 2015: 5 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HTY (Pin, Fixation, Smooth). Its devices cite 15 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 Arc Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Arc Surgical, LLC’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?

  • HWCScrew, Fixation, Bone3decisions
  • HTYPin, Fixation, Smooth1decision
  • HAWNeurological Stereotaxic Instrument1decision

Whose devices does it build on?

Its devices cite 15 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K063244Arc Surgical Bone Reduction ScrewArc Surgical, LLC · 20061cites it

What has FDA decided for it lately?

  • K141559V-Guide for VentriculostomiesArc Surgical, LLC · 2015
  • K071616Arc Surgical Biotrak Pin SystemArc Surgical, LLC · 2007
  • K063244Arc Surgical Bone Reduction ScrewArc Surgical, LLC · 2006
  • K061763Arc Surgical Biotrak ScrewArc Surgical, LLC · 20061 recall
  • K043176Arc Surgical Resorbable Compression Screw SystemArc Surgical, LLC · 2005

All 5 as Arc Surgical, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K061763Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in…Aug 21, 2009