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Cancellous Bone Screw

by Dow Corning Wright 510(k)

Active United States

510(k) K864626

Overview

A cancellous bone screw is an orthopedic device designed for fixation in spongy bone. It is used to stabilize fractures or bone grafts in areas with low bone density, such as the vertebral bodies or metaphyseal regions.

This device is supplied as a reusable or single-use implant depending on the specific model and is intended for use in orthopedic surgical settings. It received FDA 510(k) clearance (K864626) on December 15, 1986, as substantially equivalent to a predicate device, and is classified under product code HWC with Orthopedic advisory committee review.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864626 Date15 Dec 1986ClearedStatusActive

Coverage

1 jurisdiction

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  • 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  • Withdrawn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
SESE Substantially Equivalent

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Questions

  • What is the cancellous bone screw used for?

    The cancellous bone screw is designed for fixation in spongy bone to stabilize fractures or bone grafts in areas with low bone density, such as vertebral bodies or metaphyseal regions, based on its intended use in orthopedic surgical settings.

  • Is the cancellous bone screw reusable or single-use?

    The device is supplied as either reusable or single-use depending on the specific model, as indicated in the description, which states it is intended for use in orthopedic surgical settings with variability based on model.

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

    The device received FDA 510(k) clearance (K864626) on December 15, 1986, as substantially equivalent to a predicate device, following a traditional clearance process with Orthopedic advisory committee review.