Skip to content

Cancellous Bone Screw

by Onyx Medical Corp. 510(k)

Active United States

510(k) K934615

Overview

A cancellous bone screw is an orthopedic device designed for fixation in cancellous (spongy) bone. It is substantially equivalent for some indications as determined by FDA 510(k) clearance.

This device is supplied by Onyx Medical Corp. and has received FDA 510(k) clearance under K934615. It is classified as a Class II medical device with product code HWC and was cleared via the traditional pathway following a 210-day review.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK934615 Date25 Apr 1994DecidedStatusActive

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

0 recalls · FDA

No FDA recalls on record, 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
SN

Other devices from Onyx Medical LLC

See all devices from Onyx Medical LLC →

Questions

  • What is the cancellous bone screw used for?

    The cancellous bone screw is an orthopedic device designed for fixation in cancellous (spongy) bone, providing stability in areas with lower bone density where cortical screws may not hold effectively.

  • How is the cancellous bone screw supplied and is it sterile?

    The device is supplied by Onyx Medical Corp. as a sterile, single-use implant intended for surgical implantation; it is not meant to be reused after removal from the body.

  • What regulatory pathway was used for the cancellous bone screw?

    The cancellous bone screw received FDA 510(k) clearance under K934615 via the traditional review pathway following a 210-day evaluation, confirming substantial equivalence for some indications.