Cleared Special

K130147 - ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)

K130147 is an FDA 510(k) clearance for ANATOMIC ANKLE ARTHRODESIS INTERLOCKING..., manufactured by Small Bone Innovations, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 101-day FDA review.

K130147 · Small Bone Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
101d
Days
Class 2
Risk

K130147 is an FDA 510(k) clearance for the ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL). Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Small Bone Innovations, Inc. (Morrisville, US). The FDA issued a Cleared decision on May 3, 2013 after a review of 101 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K130147

510(k) Number K130147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2013
Decision Date May 03, 2013
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
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 511
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K130147.
EBA2 FEMORAL NAILING SYSTEM
K131005 · Citieffe S.R.L. · Jun 2013
PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
K123810 · CarboFix Orthopedics , Ltd. · Jun 2013
ANTEGRADE FEMORAL NAIL
K123569 · Advanced Orthopaedic Solutions, Inc. · May 2013
SIGN PEDIATRIC FIN NAIL
K122823 · Sign Fracture Care International · Apr 2013
12MM AND 13MM TIBIAL NAILS
K130625 · Advanced Orthopaedic Solutions, Inc. · Mar 2013
SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL
K123745 · Biomecanica Industria E Comerico DE Productos Orto · Mar 2013