Cleared Traditional

K122823 - SIGN PEDIATRIC FIN NAIL

K122823 is an FDA 510(k) clearance for SIGN PEDIATRIC FIN NAIL, manufactured by Sign Fracture Care International. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K122823 · Sign Fracture Care International · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
214d
Days
Class 2
Risk

K122823 is an FDA 510(k) clearance for the SIGN PEDIATRIC FIN NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Sign Fracture Care International (Richland, US). The FDA issued a Cleared decision on April 16, 2013 after a review of 214 days - an extended review 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: 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 Sign Fracture Care International devices

FDA 510(k) Submission Details - K122823

510(k) Number K122823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2012
Decision Date April 16, 2013
Days to Decision 214 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
92d slower than avg
Panel avg: 122d · This submission: 214d
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 379
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K122823.
PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
K123810 · CarboFix Orthopedics , Ltd. · Jun 2013
ANTEGRADE FEMORAL NAIL
K123569 · Advanced Orthopaedic Solutions, Inc. · May 2013
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)
K130147 · Small Bone Innovations, Inc. · May 2013
12MM AND 13MM TIBIAL NAILS
K130625 · Advanced Orthopaedic Solutions, Inc. · Mar 2013
GAMMA3 AND T2 RECON TARGETING DEVICES
K123401 · Stryker Trauma AG · Jan 2013
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
K122170 · Smith & Nephew, Inc. · Oct 2012