Cleared Special

K023437 - FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL (FDA 510(k) Clearance)

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

K023437 · Disco-O-Tech Medical Technologies, Ltd. · Orthopedic device
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Nov 2002
Decision
30d
Days
Class 2
Risk

K023437 is an FDA 510(k) clearance for the FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF N.... 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 November 14, 2002 after a review of 30 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 K023437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date November 14, 2002
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 522
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