Cleared Traditional

K063225 - METAIZEAU NAILING SYSTEM

K063225 is the FDA 510(k) clearance for METAIZEAU NAILING SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K063225 · Howmedica Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2006
Decision
64d
Days
Class 2
Risk

K063225 is an FDA 510(k) clearance for the METAIZEAU NAILING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on December 27, 2006 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 K063225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2006
Decision Date December 27, 2006
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 323
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K063225.
SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
K070843 · Synthes (Usa) · May 2007
SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES
K070294 · Synthes (Usa) · Mar 2007
BIOMET TIBIAL LOCKING NAIL SYSTEM
K063570 · Biomet Manufacturing Corp · Feb 2007
SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
K061910 · Synthes (Usa) · Sep 2006
S2 RECON NAIL SYSTEM
K060921 · Howmedica Osteonics Corp. · Apr 2006
ORTHOFIX TITANIUM NAILING SYSTEMS
K053261 · Orthofix Srl · Dec 2005