Cleared Traditional

K101934 - DYNNAIL

K101934 is the FDA 510(k) clearance for DYNNAIL by Medshape Solutions. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 387-day FDA review.

K101934 · Medshape Solutions · Orthopedic device
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Aug 2011
Decision
387d
Days
Class 2
Risk

K101934 is an FDA 510(k) clearance for the DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-.... Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Medshape Solutions (Atlanta, US). The FDA issued a Cleared decision on August 3, 2011 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medshape Solutions devices

Submission Details

510(k) Number K101934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2010
Decision Date August 03, 2011
Days to Decision 387 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
265d slower than avg
Panel avg: 122d · This submission: 387d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 319
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K101934.
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
K120083 · Synthes (Usa) · Feb 2012
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
K111891 · Synthes USA Products, LLC · Nov 2011
T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
K112059 · Stryker · Aug 2011
TRIGEN LOW PROFILE BONE SCREW
K111025 · Smith & Nephew, Inc. · Jul 2011
UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
K111444 · DePuy Orthopaedics, Inc. · Jun 2011
VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW
K110552 · Wrightmedicaltechnologyinc · Mar 2011