Cleared Traditional

ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM (K090596) - FDA 510(k) Clearance

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

K090596 · Zimmer, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2009
Decision
117d
Days
Class 2
Risk

K090596 is an FDA 510(k) clearance for the ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS.... Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 30, 2009 after a review of 117 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K090596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2009
Decision Date June 30, 2009
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
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 256
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K090596.
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
SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)
K090241 · Synthes (Usa) · Jun 2009
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS
K083497 · Zimmer, Inc. · Feb 2009
MODIFICATION TO T2 RECON NAIL SYSTEM
K083437 · Howmedica Osteonics Corp. · Dec 2008