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Austin-Moore Type Hip Prosthesis

by Osteo Technology, Inc.

510(k) K922860

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922860 Date12 Feb 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An Austin-Moore Type Hip Prosthesis is a metallic, one-piece hemi-hip replacement prosthesis designed for articulation with the natural acetabulum. It features a fixed-head design and includes fenestrations to facilitate cement interdigitation.

The device is intended for cemented use only in patients undergoing hemi-hip replacement procedures. It is supplied as a sterile, single-use implant and is classified as a Class 2 orthopedic device under product code JDI, with FDA 510(k) clearance K922860 obtained through the Traditional pathway.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Austin-Moore Type Hip Prosthesis used for?

    The Austin-Moore Type Hip Prosthesis is intended for cemented use only in patients undergoing hemi-hip replacement procedures, where it articulates with the natural acetabulum as a metallic one-piece implant.

  • How is the Austin-Moore Type Hip Prosthesis supplied and is it reusable?

    The device is supplied as a sterile, single-use implant, meaning it is provided in a sterile package for one-time surgical use and is not designed for cleaning, resterilization, or reuse.

  • What design features does the Austin-Moore Type Hip Prosthesis have to support fixation?

    It features a fixed-head design and includes fenestrations (openings) in the stem to facilitate cement interdigitation, which enhances mechanical fixation when used with bone cement in cemented hemi-hip procedures.

  • What regulatory pathway and classification apply to the Austin-Moore Type Hip Prosthesis?

    The device is classified as a Class 2 orthopedic device under product code JDI and obtained FDA 510(k) clearance K922860 through the Traditional pathway, demonstrating substantial equivalence to a predicate device.