Cleared Special

K063616 - TRIDENT II ACETABULAR SYSTEM

K063616 is the FDA 510(k) clearance for TRIDENT II ACETABULAR SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Special 510(k) pathway after a 15-day FDA review.

K063616 · Howmedica Osteonics Corp. · Orthopedic device
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Dec 2006
Decision
15d
Days
Class 2
Risk

K063616 is an FDA 510(k) clearance for the TRIDENT II ACETABULAR SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on December 20, 2006 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K063616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2006
Decision Date December 20, 2006
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K063616.
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
K070554 · DePuy Orthopaedics, Inc. · Sep 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
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EXACTECH NOVATION CROWN CUP AND LINERS
K070479 · Exactech, Inc. · Mar 2007
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
K062997 · Biomet Manufacturing Corp · Dec 2006
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
K062748 · DePuy Orthopaedics, Inc. · Nov 2006
NOVATION SPLINED RDD FEMORAL STEMS
K063279 · Exactech, Inc. · Nov 2006