Cleared Special

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) (K021324) - FDA 510(k) Clearance

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

K021324 · Disco-O-Tech Medical Technologies, Ltd. · Orthopedic device
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May 2002
Decision
27d
Days
Class 2
Risk

K021324 is an FDA 510(k) clearance for the FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM). 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 May 23, 2002 after a review of 27 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 K021324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2002
Decision Date May 23, 2002
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 K021324.
TITANIUM ANKLE ARTHRODESIS NAIL
K021786 · Biomet, Inc. · Aug 2002
S2 TIBIAL NAIL
K022481 · Howmedica Osteonics Corp. · Aug 2002
T2 FEMORAL NAIL
K021744 · Howmedica Osteonics Corp. · Jun 2002
T2 ARTHRODESIS NAIL SYSTEM
K020384 · Howmedica Osteonics Corp. · May 2002
S2 FEMORAL NAIL
K021026 · Howmedica Osteonics Corp. · Apr 2002
S2 TIBIAL NAIL
K021027 · Howmedica Osteonics Corp. · Apr 2002