Cleared Traditional

K122210 - NEWFIX EXTERNAL FIXATION SYSTEM

K122210 is an FDA 510(k) clearance for NEWFIX EXTERNAL FIXATION SYSTEM, manufactured by Tecnologia Y Diseno Industrial, S.A DE C.V. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K122210 · Tecnologia Y Diseno Industrial, S.A DE C.V · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
268d
Days
Class 2
Risk

K122210 is an FDA 510(k) clearance for the NEWFIX EXTERNAL FIXATION SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Tecnologia Y Diseno Industrial, S.A DE C.V (South Lyon, US). The FDA issued a Cleared decision on April 19, 2013 after a review of 268 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tecnologia Y Diseno Industrial, S.A DE C.V devices

FDA 510(k) Submission Details - K122210

510(k) Number K122210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2012
Decision Date April 19, 2013
Days to Decision 268 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
146d slower than avg
Panel avg: 122d · This submission: 268d
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 313
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K122210.
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K130907 · Stryker Trauma AG · Jun 2013
ILIZAROV DRILL TIP WIRES
K130479 · Smith & Nephew, Inc. · May 2013
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)
K130334 · Stryker Trauma AG · May 2013
SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM
K130044 · Wrightmedicaltechnologyinc · Apr 2013
HOFFMANN 3
K122284 · Stryker Corp. · Oct 2012
ORTHOFIX GALAXY FIXATION SYSTEM
K113770 · Orthofix Srl · Sep 2012