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Modification to Titanium Tri-Lock Hips Stem

by Depuy Orthopaedics, Inc.

510(k) K010367

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK010367 Date9 Mar 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LPH
Device class
Class II
Regulation
21 CFR Part 888.3358
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a modification to a titanium tri-lock hip stem, intended for use in hip arthroplasty procedures. It is designed to provide femoral fixation in total hip replacement systems.

The device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user. It is manufactured by DePuy Orthopaedics, Inc. and received FDA 510(k) clearance (K010367) on March 9, 2001, as substantially equivalent to a predicate device.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Modification to Titanium Tri-Lock Hip Stem used for?

    This device is intended for use in hip arthroplasty procedures to provide femoral fixation in total hip replacement systems. It is a modification to a titanium tri-lock hip stem designed to secure the femoral component during hip replacement surgery.

  • How is the Modification to Titanium Tri-Lock Hip Stem supplied and prepared for use?

    The device is supplied non-sterile by the manufacturer. It is intended for reuse after appropriate cleaning and sterilization by the user, meaning the healthcare facility must reprocess it before each surgical use.

  • Is the Modification to Titanium Tri-Lock Hip Stem a single-use or reusable device?

    The device is intended for reuse after appropriate cleaning and sterilization by the user. It is not designed as a single-use product and must be reprocessed according to validated methods before each implantation.

  • What regulatory pathway was used for the Modification to Titanium Tri-Lock Hip Stem?

    The device received FDA 510(k) clearance (K010367) on March 9, 2001, as substantially equivalent to a predicate device. This indicates it was cleared through the 510(k) premarket notification process.