Cleared Traditional

K090857 - VALOR ANKLE FUSION NAIL SYSTEM

K090857 is the FDA 510(k) clearance for VALOR ANKLE FUSION NAIL SYSTEM by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K090857 · Wrightmedicaltechnologyinc · Orthopedic device
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Jul 2009
Decision
106d
Days
Class 2
Risk

K090857 is an FDA 510(k) clearance for the VALOR ANKLE FUSION NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 14, 2009 after a review of 106 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K090857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2009
Decision Date July 14, 2009
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
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 337
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K090857.
SURESHOT TAN NAILS AND ACCESSORIES
K092748 · Smith & Nephew, Inc. · Apr 2010
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
K091566 · Zimmer GmbH · Oct 2009
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
K092646 · Synthes (Usa) · Sep 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
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
K083726 · OrthoPediatrics Corp. · Mar 2009