Cleared Traditional

K012078 - RADIOFIX

K012078 is an FDA 510(k) clearance for RADIOFIX, manufactured by Fixano SA. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K012078 · Fixano SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
87d
Days
Class 2
Risk

K012078 is an FDA 510(k) clearance for the RADIOFIX. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Fixano SA (La Jolla, US). The FDA issued a Cleared decision on September 27, 2001 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fixano SA devices

FDA 510(k) Submission Details - K012078

510(k) Number K012078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2001
Decision Date September 27, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 342
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K012078.
EBI XFIX ACCESS PELVIC FIXATOR
K013540 · Ebi, L.P. · Nov 2001
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
K013503 · DePuy Orthopaedics, Inc. · Nov 2001
EBI XFIX DFS SYSTEM
K013378 · Ebi, L.P. · Nov 2001
EBI XFIX DFS SYSTEM
K012024 · Ebi, L.P. · Jul 2001
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM
K011711 · Ebi, L.P. · Jun 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034 · Synthes (Usa) · Jun 2001