Cleared Traditional

K013475 - TRIDENT POROUS TITANIUM ACETABULAR COMP...

K013475 is the FDA 510(k) clearance for TRIDENT POROUS TITANIUM ACETABULAR COMP... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K013475 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
62d
Days
Class 2
Risk

K013475 is an FDA 510(k) clearance for the TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING. 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 December 20, 2001 after a review of 62 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K013475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2001
Decision Date December 20, 2001
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 444
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K013475.
TRIDENT ELEVATED RIM LINER
K020497 · Howmedica Osteonics Corp. · Mar 2002
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
K020170 · Encore Orthopedics, Inc. · Feb 2002
CEMENTED CALCAR HIP SYSTEM
K013490 · Encore Orthopedics, Inc. · Jan 2002
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · Smith & Nephew, Inc. · Dec 2001
CONVERGE ACETABULAR SYSTEM
K012739 · Sulzer Orthopedics, Inc. · Nov 2001
AML HIP PROSTHESIS
K012364 · DePuy Orthopaedics, Inc. · Oct 2001