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Orthomet Austin-Moore System

by Orthomet, Inc.

510(k) K871656

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 NumberK871656 Date9 Jun 1987ClearedStatusActive

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  • Withdrawn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
KWL
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Orthomet Austin-Moore System is a metal femoral hemi-prosthesis used for hip replacement procedures. It is designed to replace the femoral head and neck portion of the hip joint in patients requiring surgical intervention.

This device is supplied as a single-use implant and is regulated under FDA 510(k) clearance with product code KWL. The system is manufactured by Orthomet, Inc. and is available in various sizes as indicated by the multiple model numbers listed in the device data.

Other devices from Orthomet, Inc.

See all devices from Orthomet, Inc. →

Questions

AI-generated answers, 19 Sep 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 Orthomet Austin-Moore System used for?

    The Orthomet Austin-Moore System is a metal femoral hemi-prosthesis designed to replace the femoral head and neck portion of the hip joint in patients requiring surgical intervention for hip replacement procedures.

  • How is the Orthomet Austin-Moore System supplied and is it reusable?

    The device is supplied as a single-use implant, meaning it is intended for one-time use during a surgical procedure and should not be reprocessed or reused after implantation.

  • What regulatory pathway was used for the Orthomet Austin-Moore System?

    The Orthomet Austin-Moore System received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device, with product code KWL and clearance type Traditional.

  • What sizes or models are available for the Orthomet Austin-Moore System?

    The system is available in various sizes as indicated by multiple model numbers, though specific size dimensions are not provided in the device data; the availability of multiple models reflects a range of sizes to accommodate different patient anatomies.

  • Who manufactures the Orthomet Austin-Moore System and where is it located?

    The Orthomet Austin-Moore System is manufactured by Orthomet, Inc., located at 6301 Cecilia Cir., Minneapolis, MN 55439, United States.