Cleared Special

K142602 - VALOR Hindfoot Fusion Nail System

K142602 is an FDA 510(k) clearance for VALOR Hindfoot Fusion Nail System, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 37-day FDA review.

K142602 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
37d
Days
Class 2
Risk

K142602 is an FDA 510(k) clearance for the VALOR Hindfoot Fusion Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on October 22, 2014 after a review of 37 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K142602

510(k) Number K142602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2014
Decision Date October 22, 2014
Days to Decision 37 days
Submission Type Special
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
85d faster than avg
Panel avg: 122d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

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 461
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K142602.
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM
K141571 · Orthofix Srl · Nov 2014
INS HILDEN TIBIAL ARZZT
K133166 · Truemed Group, LLC · Nov 2014
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
K142281 · Zimmer, Inc. · Oct 2014
RESIDUAL LIMB LENGTHENING SYSTEM
K141739 · Ellipse Technologies, Inc. · Oct 2014
EMERGE MEDICAL IM NAIL SYSTEM
K141347 · Emerge Medical · Oct 2014
INTRAMEDULLARY NAIL AND SCREWS-NEONAIL
K141103 · Neoortho Produtos Ortopedicos S/A · Sep 2014