Cleared Traditional

ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )

K112982 · Small Bone Innovations, Inc. · Orthopedic
Apr 2012
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K112982 is an FDA 510(k) clearance for the ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ), a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Small Bone Innovations, Inc. (Morrisville, US). The FDA issued a Cleared decision on April 2, 2012, 179 days after receiving the submission on October 6, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K112982 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2011
Decision Date April 02, 2012
Days to Decision 179 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

Similar Devices — HSB Rod, Fixation, Intramedullary And Accessories

All 519
Affixus Retrograde Femoral Nailing System
K253566 · Zimmer, Inc. · Mar 2026
Reselute Tibial Nail
K253517 · Reselute, Inc. · Mar 2026
Arthrex FibuLock Nail System
K252196 · Arthrex, Inc. · Mar 2026
Phantom? Hindfoot TTC/TC Nail System
K253591 · Paragon 28, Inc. · Mar 2026
Active Intramedullary (AIM) Tibial Nail System
K252025 · Satori Orthopaedics, Inc. · Mar 2026
T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
K253640 · Stryker GmbH · Feb 2026