Skip to content

Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500

by Arthrocare Corp. 510(k)

Active United States

510(k) K081893

Overview

The Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500, is a bone fixation screw system designed to function as a mechanical fixation fastener. It is used in arthroscopic and orthopedic procedures to secure soft tissue to bone.

This device includes an inserter handle and is operated by surgeons in clinical or operating room settings. It has received FDA 510(k) clearance under the classification of a bone fixation screw.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081893 Date1 Oct 2008ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from ArthroCare Corporation

See all devices from ArthroCare Corporation →

Questions

  • What is the primary function of the Opus Magnum Speedscrew OM-6500?

    The device is designed as a mechanical fixation fastener used by surgeons during arthroscopic and orthopedic procedures to securely attach soft tissue to bone.

  • What components are included with the OM-6500 fixation device?

    The system is supplied with an inserter handle, which allows the surgeon to operate the device effectively within a clinical or operating room environment.

  • What is the regulatory status of this fixation device?

    The Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500, has received FDA 510(k) clearance under the classification of a bone fixation screw, as documented under K-number K081893.