Cleared Traditional

K120419 - DYNA LOCKING ANKLE NAIL

K120419 is an FDA 510(k) clearance for DYNA LOCKING ANKLE NAIL, manufactured by U&I Corp.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K120419 · U&I Corp. · Orthopedic device
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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

FDA 510(k) Submission Details - K120419

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.

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 381
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K120419.
AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW
K120148 · Advanced Orthopaedic Solutions, Inc. · Oct 2012
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
K120715 · Zimmer GmbH · Aug 2012
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