510(k) Report

FDA applicant

Opus Medical, Inc.

San Juan Capistrano, CA13 decisions2001–20047 recalls

FDA records 13 decisions for Opus Medical, Inc. (San Juan Capistrano, CA) from 2001 to 2004: 13 510(k) clearances. Most are in product codes OCW (Endoscopic Tissue Approximation Device) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 3 predicates, 3 of them its own earlier devices. 7 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, orthopedic panel, where it files most

How often FDA has decided Opus Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Opus Medical, Inc. since 2007.

Recalls per year

4in 2011

2011: 4
2007high 4 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Opus Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OCWEndoscopic Tissue Approximation Device4decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue3decisions
  • HTYPin, Fixation, Smooth2decisions
  • GEXPowered Laser Surgical Instrument2decisions
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene1decision
  • HWCScrew, Fixation, Bone1decision

Who builds on its devices?

Later devices cite its devices 21 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.

  • K012125Opus Magnum Anchor & InserterOpus Medical, Inc. · 20014cite it
  • K030235F1 Diode Laser SystemOpus Medical, Inc. · 20034cite it
  • K042031Opus Speedstitch Suture DeviceOpus Medical, Inc. · 20043cite it
  • K042584Opus Minimagnum Anchor with InserterOpus Medical, Inc. · 20043cite it
  • K042914Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 20043cite it
  • K033317Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070Opus Medical, Inc. · 20031cites it

What has FDA decided for it lately?

  • K042584Opus Minimagnum Anchor with InserterOpus Medical, Inc. · 20043 recalls
  • K042914Opus Magnum Knotless Anchor with Inserter HandleOpus Medical, Inc. · 2004
  • K042031Opus Speedstitch Suture DeviceOpus Medical, Inc. · 20041 recall
  • K041440Opus Magnum Anchor with InserterOpus Medical, Inc. · 2004
  • K033317Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070Opus Medical, Inc. · 2003
  • K030170Reusable Smartstitch Suture Device, Models OM-8007, OM-8500Opus Medical, Inc. · 2003
  • K031083Opus Magnum Implant System, Model OM-1500Opus Medical, Inc. · 2003
  • K030235F1 Diode Laser SystemOpus Medical, Inc. · 2003

All 13 as Opus Medical, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K042031OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation…Aug 8, 2011
  • K0425845.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff…Aug 8, 2011
  • K042584OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff…Aug 8, 2011
  • K042584ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus…May 11, 2011
  • K022229OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus…Jun 28, 2006
  • K022229ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is…Jun 7, 2006

Other applicant names beginning “Opus”

FDA records each applicant name separately; these may or may not be the same firm.

Opus Ksd, Inc. 1