Cleared Special

K100497 - QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)

K100497 is an FDA 510(k) clearance for QUANTUM IM COMPOSITE NAILING SYSTEM (QU..., manufactured by N.M.B. Medical Applications, Ltd.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 119-day FDA review.

K100497 · N.M.B. Medical Applications, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
119d
Days
Class 2
Risk

K100497 is an FDA 510(k) clearance for the QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM 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 June 21, 2010 after a review of 119 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100497

510(k) Number K100497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2010
Decision Date June 21, 2010
Days to Decision 119 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

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 515
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K100497.
ASCENSION ANKLE FUSION NAIL SYSTEM
K100925 · Ascension Orthopedics, Inc. · Jul 2010
WRIST ARTHRODESIS NAIL SYSTEM
K092720 · Skeletal Dynamics, LLC · Jun 2010
DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820
K093707 · U&I Corp. · 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
K100497 · QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)
Download PDF FDA Summary N.M.B. Medical Applic…