Cleared Special

MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM (K010367) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010367 · DePuy Orthopaedics, Inc. · Orthopedic device
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Mar 2001
Decision
30d
Days
Class 2
Risk

K010367 is an FDA 510(k) clearance for the MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 9, 2001 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K010367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2001
Decision Date March 09, 2001
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 324
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K010367.
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
K011081 · Exactech, Inc. · Apr 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
K010170 · Howmedica Osteonics Corp. · Apr 2001
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
K010171 · DePuy Orthopaedics, Inc. · Apr 2001
TI-REPLICA HIP STEM
K003875 · DePuy Orthopaedics, Inc. · Mar 2001
PERFECTA AND EXTEND
K004032 · Wrightmedicaltechnologyinc · Feb 2001
AML HIP PROSTHESIS
K003800 · DePuy Orthopaedics, Inc. · Feb 2001