Cleared Special

K130625 - 12MM AND 13MM TIBIAL NAILS

K130625 is an FDA 510(k) clearance for 12MM AND 13MM TIBIAL NAILS, manufactured by Advanced Orthopaedic Solutions, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 20-day FDA review.

K130625 · Advanced Orthopaedic Solutions, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
20d
Days
Class 2
Risk

K130625 is an FDA 510(k) clearance for the 12MM AND 13MM TIBIAL NAILS. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Advanced Orthopaedic Solutions, Inc. (Torrance, US). The FDA issued a Cleared decision on March 28, 2013 after a review of 20 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.

FDA 510(k) Submission Details - K130625

510(k) Number K130625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2013
Decision Date March 28, 2013
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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 529
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K130625.
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
SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL
K123745 · Biomecanica Industria E Comerico DE Productos Orto · Mar 2013
GAMMA3 AND T2 RECON TARGETING DEVICES
K123401 · Stryker Trauma AG · Jan 2013
INTRAMEDULLARY NAIL SYSTEM
K121312 · Weigao Orthopaedic Device Co., Ltd. · Oct 2012
K130625 · 12MM AND 13MM TIBIAL NAILS
Download PDF FDA Summary Advanced Orthopaedic …