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Profemur Z Titanium Plasma Sprayed Hip Stem

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K111699

Overview

The Profemur Z Titanium Plasma Sprayed Hip Stem is a semi-constrained, uncemented metal hip prosthesis designed for use in total hip arthroplasty. It is intended as a femoral component, providing structural support and articulation within the hip joint to restore function and alleviate pain in skeletally mature patients.

This device is supplied as a single-use component, requiring pairing with ceramic or metal femoral heads for complete implantation. It is classified as a Class III medical device under FDA regulations (21 CFR 888.3330) and holds a 510(k) clearance (K111699) for orthopedic use. Multiple registration numbers (e.g., 8043792, 3020282716) correspond to its various model variants, all intended for uncemented fixation within the proximal femur.

AI-generated from registry data, 20 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 NumberK111699 Date19 Aug 2011ClearedStatusActive

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)

Full name
Profemur(R) Z Titanium Plasma Sprayed Hip Stem
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 femoral heads are compatible with the Profemur Z Titanium Plasma Sprayed Hip Stem, and how is it intended to be used in surgery?

    The Profemur Z Titanium Plasma Sprayed Hip Stem is designed to be paired with either ceramic or metal femoral heads to complete the total hip arthroplasty. It is a semi-constrained, uncemented femoral component intended for skeletally mature patients undergoing hip replacement surgery. The stem provides structural support and articulation within the hip joint to restore function and reduce pain, relying on uncemented fixation within the proximal femur.

  • Is the Profemur Z Titanium Plasma Sprayed Hip Stem intended for reuse, or is it single-use only?

    The Profemur Z Titanium Plasma Sprayed Hip Stem is explicitly supplied as a single-use component. This means it is intended for one-time use in a single patient and should not be reused or reprocessed for another procedure.

  • What storage conditions should be followed for the Profemur Z Titanium Plasma Sprayed Hip Stem?

    While the provided data does not specify exact storage conditions, the device is a sterile, single-use implant. Typically, such implants require storage in a clean, dry environment, protected from contamination, and within the manufacturer’s recommended temperature and humidity ranges. Always refer to the accompanying packaging instructions for precise storage guidelines.

  • How many model variants of the Profemur Z Titanium Plasma Sprayed Hip Stem are available, and how can I identify them?

    The Profemur Z Titanium Plasma Sprayed Hip Stem comes in multiple model variants, each associated with a unique registration number (e.g., 8043792, 3020282716, etc.). These variants are all intended for uncemented fixation within the proximal femur. The specific model can often be identified by the registration number or the product code (KWA) listed on the packaging or documentation.