Cleared Special

MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) (K032588) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032588 · Disco-O-Tech Medical Technologies, Ltd. · Orthopedic device
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Sep 2003
Decision
21d
Days
Class 2
Risk

K032588 is an FDA 510(k) clearance for the MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM). Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Disco-O-Tech Medical Technologies, Ltd. (Herzlia, IL). The FDA issued a Cleared decision on September 12, 2003 after a review of 21 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Disco-O-Tech Medical Technologies, Ltd. devices

Submission Details

510(k) Number K032588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2003
Decision Date September 12, 2003
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 K032588.
T2 NAILING SYSTEM
K032523 · Howmedica Osteonics Corp. · Oct 2003
T2 RECON NAIL SYSTEM
K032898 · Howmedica Osteonics Corp. · Oct 2003
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
K032722 · Smith & Nephew, Inc. · Oct 2003
S2 NAIL SYSTEM
K032579 · Howmedica Osteonics Corp. · Aug 2003
ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL
K032367 · Zimmer, Inc. · Aug 2003
DEPUY ACE VERSANAIL TIBIAL NAIL
K032097 · DePuy Orthopaedics, Inc. · Aug 2003