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Profemur LX 5/8 Coated Hip Stem

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K081090

Overview

The Profemur LX 5/8 Coated Hip Stem is a semi-constrained, uncemented metal acetabular prosthesis designed for hip arthroplasty. This device is intended to replace damaged or diseased femoral components, providing structural support and restoring function to the hip joint through a coated stem that promotes osseointegration with the bone.

The device is supplied as a single-use, sterile orthopedic implant and is regulated under FDA 510(k) clearance (K081090) as a Class III medical device. It is intended for use in orthopedic surgical settings and must be implanted by a qualified surgeon. The Profemur LX 5/8 Coated Hip Stem adheres to regulatory standards outlined in 21 CFR 888.3330, ensuring compliance with manufacturing and performance requirements for hip prostheses.

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 NumberK081090 Date15 May 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 is the primary purpose of the Profemur LX 5/8 Coated Hip Stem in hip arthroplasty procedures?

    The Profemur LX 5/8 Coated Hip Stem is designed as a semi-constrained, uncemented metal acetabular prosthesis to replace damaged or diseased femoral components during hip arthroplasty. Its coated stem promotes osseointegration, meaning it encourages direct bonding with bone to provide structural support and restore hip joint function.

  • Is the Profemur LX 5/8 Coated Hip Stem intended for single-use or reusable applications, and how is it supplied?

    The Profemur LX 5/8 Coated Hip Stem is supplied as a single-use, sterile orthopedic implant. This ensures patient safety by preventing cross-contamination and maintains compliance with surgical best practices for implantable devices.

  • What regulatory pathway does the Profemur LX 5/8 Coated Hip Stem follow, and what does this mean for its use?

    The device is regulated under the FDA’s 510(k) clearance pathway (K081090) as a Class III medical device, meaning it undergoes rigorous review to ensure safety and effectiveness. It is intended exclusively for use in orthopedic surgical settings by qualified surgeons, adhering to standards outlined in 21 CFR 888.3330.

  • Are there multiple sizes or models of the Profemur LX 5/8 Coated Hip Stem, and how would a surgeon determine the appropriate fit?

    While the device name specifies a 5/8-inch diameter, the provided registration numbers indicate multiple lot-specific variants (e.g., 3020282716, 3007923096) which may correspond to different sizes or configurations. Surgeons typically select the appropriate size based on preoperative imaging and patient-specific anatomy to ensure proper fit and function during hip arthroplasty.