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Altra FX Hip System

by Biomet Manufacturing Corp

510(k) K063614

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 NumberK063614 Date20 Feb 2007ClearedStatusActive

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  • Withdrawn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
KWA
Device Class
Class III
Regulation
21 CFR Part 888.3330
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Altra FX Hip System is a semi-constrained, uncemented acetabular metal prosthesis designed for total hip arthroplasty. It is classified as a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) under FDA nomenclature.

This system is intended for use in orthopedic surgical procedures and is supplied as a sterile, single-use device. It is regulated under FDA regulation number 888.3330 and received a Traditional 510(k) clearance with a Substantially Equivalent determination by the Orthopedic Devices Panel in 2007. Multiple component reference codes are listed for regulatory tracking.

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Questions

AI-generated answers, 18 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 types of surgical procedures is the Altra FX Hip System designed for?

    The Altra FX Hip System is specifically designed for total hip arthroplasty procedures. This semi-constrained, uncemented acetabular metal prosthesis is intended for use in orthopedic surgeries where a hip replacement is required, providing a stable metal component that integrates with the patient’s bone without the need for cement.

  • Is the Altra FX Hip System reusable or intended for single-use only?

    The Altra FX Hip System is supplied as a sterile, single-use device. This means each component is intended for one surgical procedure only and should not be reused, ensuring patient safety and compliance with medical device regulations.

  • How is the Altra FX Hip System regulated in the U.S.?

    The Altra FX Hip System is regulated under FDA regulation number 888.3330 and received a Traditional 510(k) clearance with a Substantially Equivalent determination by the Orthopedic Devices Panel in 2007. This classification confirms it meets FDA standards for semi-constrained, uncemented acetabular metal prostheses.

  • What does the semi-constrained feature of the Altra FX Hip System mean for its use?

    The semi-constrained design of the Altra FX Hip System provides a balance between stability and flexibility in the hip joint. This feature helps reduce dislocation risks while allowing some natural movement, making it suitable for patients who require a durable yet functional hip replacement solution.

  • Are there multiple component sizes or models available for the Altra FX Hip System?

    Yes, the Altra FX Hip System includes multiple component reference codes, indicating a range of sizes and models to accommodate different patient anatomies and surgical needs. These variations allow for customization during total hip arthroplasty to ensure a precise fit and optimal function.