Cleared Traditional

DYNA LOCKING ANKLE NAIL (K120419) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120419 · U&I Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
101d
Days
Class 2
Risk

K120419 is an FDA 510(k) clearance for the DYNA LOCKING ANKLE NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by U&I Corp. (Uijeongbu-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on May 21, 2012 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. 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. Standard predicate reliance. 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 U&I Corp. devices

Submission Details

510(k) Number K120419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2012
Decision Date May 21, 2012
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
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 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K120419.
SYNTHES SYNSONIC ULNA NAIL
K131984 · Synthes (Usa) · Mar 2014
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
K130595 · Zimmer, Inc. · Sep 2013
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
K122170 · Smith & Nephew, Inc. · Oct 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
TRIGEN LOW PROFILE BONE SCREW
K111025 · Smith & Nephew, Inc. · Jul 2011