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Profemur Hip System Modular Necks

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K091423

Overview

The Profemur Hip System Modular Necks is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for use in total hip arthroplasty. This modular system provides customizable femoral neck components to facilitate precise alignment and stability during hip replacement surgery, ensuring compatibility with various femoral stems and acetabular components.

The modular necks are intended for single-use in orthopedic surgical settings and are supplied sterile. They are classified as Class III devices under FDA regulations and have received FDA 510(k) clearance as substantially equivalent to predicate devices. Multiple sizes and configurations are available to accommodate different anatomical requirements, with regulatory compliance ensured through the specified FEI numbers and registration numbers.

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

Regulatory status

as of 28 Oct 2026

Recall ongoing on a related submission. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091423 Date25 Aug 2009ClearedStatusActive

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

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2948-2020 FDA Class II initiated 31 Jul 2020 via K091423, on the same 510(k)

    MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR Hip System Package Insert with the most recent revision (150803-8).

    • Terminated Z-2743-2015 FDA Class I initiated 4 Aug 2015 via K091423, on the same 510(k)

    Unexpected rate of postoperative fractures resulting in the need for revision surgery.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

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 surgical procedures is the Profemur Hip System Modular Necks designed for?

    The Profemur Hip System Modular Necks is specifically designed for use in total hip arthroplasty procedures. Its modular neck components are intended to provide customizable alignment and stability when paired with various femoral stems and acetabular components, ensuring compatibility for uncemented acetabular implants.

  • Are the modular necks reusable or intended for single-use only?

    The Profemur Hip System Modular Necks are explicitly intended for single-use in orthopedic surgical settings. This design ensures patient safety and sterility, as they are supplied sterile and not meant to be reused.

  • How many sizes and configurations are available for the Profemur Hip System Modular Necks?

    The system offers multiple sizes and configurations to accommodate different anatomical requirements. While the exact number of sizes isn’t specified, the device includes several FEI numbers (e.g., 3020282716, 3007923096) and registration numbers, indicating a diverse range of options for customization during surgery.

  • How should the modular necks be stored before use?

    Since the Profemur Hip System Modular Necks are supplied sterile, they should be stored according to the manufacturer’s instructions to maintain sterility. Typically, this involves keeping them in their original packaging in a clean, dry environment, protected from contamination until ready for use.

  • What regulatory pathway was followed for FDA clearance of the Profemur Hip System Modular Necks?

    The device received FDA 510(k) clearance through the traditional review pathway, classified as substantially equivalent to predicate devices. The clearance was granted under the Orthopedic advisory committee (OR) and falls under product code KWA, with a decision date of August 25, 2009.