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Tri-Lock Modified Femoral Prosthesis

by Depuy, Inc. 510(k)

Active United States

510(k) K872878

Overview

The Tri-Lock Modified Femoral Prosthesis is a metal hip hemi-prosthesis designed for femoral replacement in orthopedic surgery. It is classified as a Class II device under FDA regulations and intended for use in partial hip arthroplasty, providing structural support and restoring function to the femur.

This device is supplied as a reusable surgical implant and is intended for use in sterile operating room environments. It is regulated under FDA 510(k) clearance (K872878) and falls under the product code KWL. Multiple reference codes (e.g., 2245304, 3004748528) identify specific variants, though no details on sterility or MRI safety are provided in the data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK872878 Date7 Aug 1987DecidedStatusActive

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
KWL
Device Class
Class II
Regulation
21 CFR Part 888.3360
Advisory Committee
Orthopedic
FDA Decision
SN

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Questions

  • What types of surgical procedures is the Tri-Lock Modified Femoral Prosthesis intended for, and how does it function in those procedures?

    The Tri-Lock Modified Femoral Prosthesis is specifically designed for partial hip arthroplasty, a surgical procedure where only the femoral (thigh bone) component of the hip joint is replaced. It provides structural support to the femur by acting as a durable, metal implant, helping to restore mobility and function after conditions like fractures, degenerative joint disease, or trauma compromise the natural femoral head.

  • Is the Tri-Lock Modified Femoral Prosthesis intended for single-use or can it be reused in multiple procedures?

    The device is explicitly described as a reusable surgical implant, meaning it is intended for use in multiple procedures after proper cleaning, sterilization, and maintenance. It is designed for sterile operating room environments, ensuring safety and reliability across repeated applications.

  • How do I determine which specific variant or reference code of the Tri-Lock Modified Femoral Prosthesis is needed for a procedure?

    The Tri-Lock Modified Femoral Prosthesis comes in multiple variants, each identified by unique reference codes (e.g., 2245304, 3004748528). While the data does not specify clinical differences between these variants, the selection should be based on patient-specific anatomical requirements and surgeon preference. Consulting the manufacturer’s catalog or a surgical planning tool aligned with these codes will help ensure the correct implant is chosen.

  • What regulatory pathway was followed for the FDA clearance of the Tri-Lock Modified Femoral Prosthesis, and what does this mean for its use?

    The Tri-Lock Modified Femoral Prosthesis received FDA 510(k) clearance (K872878) under the Traditional 510(k) Review pathway, with a decision classification of 'Substantially Equivalent for Some Indications.' This means the device was determined to be as safe and effective as a legally marketed predicate device for certain applications in partial hip arthroplasty. Clinicians and buyers should confirm compatibility with their specific surgical needs and institutional protocols.