Cleared Traditional

K093707 - DYNA LOCKING TROCHANTERIC NAIL

K093707 is an FDA 510(k) clearance for DYNA LOCKING TROCHANTERIC 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 203-day FDA review.

K093707 · U&I Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
203d
Days
Class 2
Risk

K093707 is an FDA 510(k) clearance for the DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by U&I Corp. (Uijungbu, Gyeonggi-Do, KR). The FDA issued a Cleared decision on June 23, 2010 after a review of 203 days - an extended review 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: 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 - K093707

510(k) Number K093707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2009
Decision Date June 23, 2010
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 K093707.
ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS
K101622 · Zimmer, Inc. · Oct 2010
ASCENSION ANKLE FUSION NAIL SYSTEM
K100925 · Ascension Orthopedics, Inc. · Jul 2010
WRIST ARTHRODESIS NAIL SYSTEM
K092720 · Skeletal Dynamics, LLC · Jun 2010
T2 GREATER TROCHANTER NAIL
K101438 · Howmedica Osteonics Corp. · Jun 2010
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
K100238 · DePuy Orthopaedics, Inc. · May 2010
SURESHOT TAN NAILS AND ACCESSORIES
K092748 · Smith & Nephew, Inc. · Apr 2010