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Profemur LX Revision 5/8 Coated Hip Stem

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K080663

Overview

The Profemur LX Revision 5/8 Coated Hip Stem is a semi-constrained, uncemented metal prosthesis designed for hip replacement surgery. It is intended to restore function and mobility in patients with degenerative joint disease, fractures, or other conditions requiring femoral replacement.

This device is supplied as a single-use, sterile implant and is classified as a Class III medical device under FDA regulations. It is intended for use in orthopedic settings and must be implanted by a qualified surgeon following standard aseptic techniques. The Profemur LX Revision 5/8 is authorized under FDA 510(k) clearance (K080663) and adheres to regulatory standards outlined in 21 CFR 888.3330.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK080663 Date8 Apr 2008ClearedStatusActive

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

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Questions

  • What types of patients is the Profemur LX Revision 5/8 Coated Hip Stem designed to help, and how does it restore function?

    The Profemur LX Revision 5/8 Coated Hip Stem is specifically designed for patients with degenerative joint disease, fractures, or other conditions requiring femoral replacement in hip replacement surgery. It is a semi-constrained, uncemented metal prosthesis intended to restore function and mobility by replacing the damaged femoral component of the hip joint, allowing patients to regain stability and movement.

  • Is the Profemur LX Revision 5/8 Coated Hip Stem intended for reuse or is it single-use only?

    The Profemur LX Revision 5/8 Coated Hip Stem is supplied as a single-use, sterile implant. This design ensures patient safety by preventing cross-contamination and maintaining sterility for each surgical procedure.

  • What regulatory pathway was followed for FDA clearance of the Profemur LX Revision 5/8 Coated Hip Stem?

    The Profemur LX Revision 5/8 Coated Hip Stem was cleared through the FDA’s 510(k) pathway, specifically under clearance number K080663. It was determined to be substantially equivalent to a predicate device and adheres to regulatory standards outlined in 21 CFR 888.3330, with a classification as a Class III medical device.

  • How should the Profemur LX Revision 5/8 Coated Hip Stem be stored before use?

    While the provided data does not specify storage conditions explicitly, as a sterile, single-use implant, it should be stored in a clean, dry environment protected from contamination, moisture, and extreme temperatures. Always follow the manufacturer’s instructions for optimal preservation, which are typically included in the packaging.