Cleared Traditional

K022771 - TWIN FIX

K022771 is an FDA 510(k) clearance for TWIN FIX, 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 33-day FDA review.

K022771 · Fixano SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
33d
Days
Class 2
Risk

K022771 is an FDA 510(k) clearance for the TWIN FIX. 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 23, 2002 after a review of 33 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 - K022771

510(k) Number K022771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2002
Decision Date September 23, 2002
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
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 K022771.
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EBI XFIX DFS SYSTEM
K023399 · Ebi, L.P. · Oct 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K023324 · Ebi, L.P. · Oct 2002
TEMPFIX EXTERNAL FIXATION SYSTEM
K021933 · DePuy Orthopaedics, Inc. · Aug 2002
EBI XFIX DFS SYSTEM
K022319 · Ebi, L.P. · Aug 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012623 · Alliance Medical Corp. · Jun 2002