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Profemur Gladiator HA Hip Stem

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K112150

Overview

The Profemur Gladiator HA Hip Stem is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for total hip arthroplasty. This modular, cementless hip prosthesis features a proximal trapezoidal cross-section and a distal rectangular cross-section with a vertically tapered profile, providing three-plane fixation stability. Constructed from Ti-6Al-4V alloy with a hydroxyapatite plasma spray coating, it is intended for uncemented fixation in the femur.

The device is supplied in 10 sizes and is intended for use in orthopedic surgical settings. It is classified as a Class III medical device under FDA regulations and has received FDA 510(k) clearance (K112150). The stem is non-sterile as shipped and requires sterilization prior to use. No specific MRI safety information is provided in the data, and regulatory authorisations are limited to the stated FDA_510K clearance.

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 · Traditional NumberK112150 Date23 Nov 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)

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 Gladiator HA Hip Stem and how does its design support this purpose?

    The Profemur Gladiator HA Hip Stem is designed for total hip arthroplasty, specifically as a cementless femoral prosthesis for uncemented fixation in the femur. Its modular, trapezoidal-proximal and rectangular-distal cross-section with a vertically tapered profile provides three-plane fixation stability, enhancing osseointegration and long-term implant security without cement.

  • How many sizes are available for the Profemur Gladiator HA Hip Stem, and what material is it made from?

    The device is supplied in 10 distinct sizes to accommodate varying femoral anatomies. It is constructed from Ti-6Al-4V alloy with a hydroxyapatite plasma spray coating, which promotes bone growth and stability in uncemented applications.

  • Is the Profemur Gladiator HA Hip Stem sterile as shipped, and if not, what sterilization is required before use?

    The Profemur Gladiator HA Hip Stem is non-sterile as shipped and must undergo sterilization prior to surgical use. The manufacturer does not specify a sterilization method in the provided data, so clinicians should follow their facility’s validated protocols for metal implants.

  • What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

    The Profemur Gladiator HA Hip Stem received FDA 510(k) clearance (K112150) under a Traditional review pathway, determined to be substantially equivalent to a predicate device. The Orthopedic (OR) Advisory Committee was involved in the review process, as indicated by the submission details.