Cleared Traditional

K010170 - TRIDENT POROUS TITANIUM ACETABULAR COMPONENT

K010170 is an FDA 510(k) clearance for TRIDENT POROUS TITANIUM ACETABULAR COMP..., manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K010170 · Howmedica Osteonics Corp. · Orthopedic device
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Apr 2001
Decision
90d
Days
Class 2
Risk

K010170 is an FDA 510(k) clearance for the TRIDENT POROUS TITANIUM ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 18, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K010170

510(k) Number K010170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2001
Decision Date April 18, 2001
Days to Decision 90 days
Submission Type Traditional
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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

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 539
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K010170.
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX)
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SUMMIT DUOFIX HIP PROSTHESIS
K011489 · DePuy Orthopaedics, Inc. · Jul 2001
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
K011081 · Exactech, Inc. · Apr 2001
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
K010171 · DePuy Orthopaedics, Inc. · Apr 2001
MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM
K010367 · DePuy Orthopaedics, Inc. · Mar 2001
TI-REPLICA HIP STEM
K003875 · DePuy Orthopaedics, Inc. · Mar 2001