Cleared Traditional

K063816 - PCA ALUMINA FEMORAL HEADS

K063816 is an FDA 510(k) clearance for PCA ALUMINA FEMORAL HEADS, manufactured by Stryker Orthopaedics. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K063816 · Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
42d
Days
Class 2
Risk

K063816 is an FDA 510(k) clearance for the PCA ALUMINA FEMORAL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on February 2, 2007 after a review of 42 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. 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 Stryker Orthopaedics devices

FDA 510(k) Submission Details - K063816

510(k) Number K063816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date February 02, 2007
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

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 451
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K063816.
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
K070554 · DePuy Orthopaedics, Inc. · Sep 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
K070885 · Howmedica Osteonics Corp. · May 2007
EXACTECH NOVATION CROWN CUP AND LINERS
K070479 · Exactech, Inc. · Mar 2007
TRIDENT II ACETABULAR SYSTEM
K063616 · Howmedica Osteonics Corp. · Dec 2006
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