Cleared Traditional

K113828 - DYNANAIL ANKLE ARTHRODESIS NAIL

K113828 is an FDA 510(k) clearance for DYNANAIL ANKLE ARTHRODESIS NAIL, manufactured by MedShape, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K113828 · MedShape, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
64d
Days
Class 2
Risk

K113828 is an FDA 510(k) clearance for the DYNANAIL ANKLE ARTHRODESIS NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by MedShape, Inc. (Atlanta, US). The FDA issued a Cleared decision on February 29, 2012 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all MedShape, Inc. devices

FDA 510(k) Submission Details - K113828

510(k) Number K113828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2011
Decision Date February 29, 2012
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 K113828.
SYNTHES MULTILOC HUMERAL NAILING SYSTEM
K120807 · Synthes USA Products, LLC · Jul 2012
OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
K120978 · Merete Medical GmbH · May 2012
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
K112982 · Small Bone Innovations, Inc. · Apr 2012
S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL
K113409 · Howmedica Osteonics Corp. · Feb 2012
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
K120083 · Synthes (Usa) · Feb 2012
OSLEOBRIDGE IDSF SPACER CONECTOR
K113303 · Merete Medical GmbH · Dec 2011