Cleared Traditional

K090596 - ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM

K090596 is an FDA 510(k) clearance for ZIMMER NATURAL NAIL SYSTEM STAINLESS ST..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K090596 · Zimmer, Inc. · Orthopedic device
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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

FDA 510(k) Submission Details - K090596

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.

HSB Device Classification - Class 2, Special Controls

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 465
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K090596.
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
K091566 · Zimmer GmbH · Oct 2009
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
AOS PROXIMAL HUMERAL NAIL
K090478 · Advanced Orthopaedic Solutions, Inc. · Mar 2009
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
K083726 · OrthoPediatrics Corp. · Mar 2009