Cleared Traditional

K123810 - PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM

K123810 is an FDA 510(k) clearance for PICCOLO COMPOSITE ANKLE ARTHRODESIS NAI..., manufactured by CarboFix Orthopedics , Ltd.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K123810 · CarboFix Orthopedics , Ltd. · Orthopedic device
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Jun 2013
Decision
185d
Days
Class 2
Risk

K123810 is an FDA 510(k) clearance for the PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by CarboFix Orthopedics , Ltd. (Herzliya, IL). The FDA issued a Cleared decision on June 14, 2013 after a review of 185 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 CarboFix Orthopedics , Ltd. devices

FDA 510(k) Submission Details - K123810

510(k) Number K123810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2012
Decision Date June 14, 2013
Days to Decision 185 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
63d slower than avg
Panel avg: 122d · This submission: 185d
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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K123810.
RETROGRADE FEMORAL NAIL
K132005 · Advanced Orthopaedic Solutions, Inc. · Sep 2013
611 ANKLE FUSION NAIL
K130051 · Tornier S.A.S. · Jul 2013
EBA2 FEMORAL NAILING SYSTEM
K131005 · Citieffe S.R.L. · 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
SIGN PEDIATRIC FIN NAIL
K122823 · Sign Fracture Care International · Apr 2013