Cleared Traditional

PICCOLO COMPOSITE NAILING SYSTEM (K102369) - FDA 510(k) Clearance

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

K102369 · N.M.B. Medical Applications, Ltd. · Orthopedic device
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Jan 2011
Decision
164d
Days
Class 2
Risk

K102369 is an FDA 510(k) clearance for the PICCOLO COMPOSITE NAILING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by N.M.B. Medical Applications, Ltd. (Herzliya, IL). The FDA issued a Cleared decision on January 31, 2011 after a review of 164 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 N.M.B. Medical Applications, Ltd. devices

Submission Details

510(k) Number K102369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2010
Decision Date January 31, 2011
Days to Decision 164 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
42d slower than avg
Panel avg: 122d · This submission: 164d
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 K102369.
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
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
K103002 · Synthes (Usa) · Mar 2011
T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
K102992 · Howmedica Osteonics Corp. · Dec 2010
ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS
K101622 · Zimmer, Inc. · Oct 2010
T2 GREATER TROCHANTER NAIL
K101438 · Howmedica Osteonics Corp. · Jun 2010