Cleared Special

K012967 - MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM

K012967 is an FDA 510(k) clearance for MODIFICATION TO FIXION INTERLOCKING PRO..., manufactured by Disco-O-Tech Medical Technologies, Ltd.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 30-day FDA review.

K012967 · Disco-O-Tech Medical Technologies, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
30d
Days
Class 2
Risk

K012967 is an FDA 510(k) clearance for the MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING S.... 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 October 4, 2001 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.

FDA 510(k) Submission Details - K012967

510(k) Number K012967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2001
Decision Date October 04, 2001
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
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 529
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K012967.
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · DePuy Orthopaedics, Inc. · Dec 2001
LONG LENGTH DYAX NAIL
K013468 · Howmedica Osteonics Corp. · Nov 2001
TROCHANTERIC DYAX NAIL SYSTEM
K013524 · Howmedica Osteonics Corp. · Nov 2001
AOS MODULAR FEMORAL NAIL
K012190 · Advanced Orthopaedic Solutions, Inc. · Sep 2001
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
K011857 · Synthes (Usa) · Sep 2001
MODIFICATION TO: LONG LENGTH GAMMA NAIL
K012158 · Howmedica Osteonics Corp. · Aug 2001
K012967 · MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
Download PDF FDA Summary Disco-O-Tech Medical …