Cleared Traditional

BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL (K091976) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091976 · Biomet Trauma · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2009
Decision
47d
Days
Class 2
Risk

K091976 is an FDA 510(k) clearance for the BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Biomet Trauma (Parsippany, US). The FDA issued a Cleared decision on August 17, 2009 after a review of 47 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 Biomet Trauma devices

Submission Details

510(k) Number K091976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date August 17, 2009
Days to Decision 47 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 122d · This submission: 47d
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 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K091976.
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
K100238 · DePuy Orthopaedics, Inc. · May 2010
SURESHOT TAN NAILS AND ACCESSORIES
K092748 · Smith & Nephew, Inc. · Apr 2010
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
K092646 · Synthes (Usa) · Sep 2009
VALOR ANKLE FUSION NAIL SYSTEM
K090857 · Wrightmedicaltechnologyinc · Jul 2009
ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM
K090596 · Zimmer, Inc. · Jun 2009
SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)
K090241 · Synthes (Usa) · Jun 2009