Cleared Traditional

K131413 - XTRAFIX SMALL EXTERNAL FIXATION SYSTEM

K131413 is an FDA 510(k) clearance for XTRAFIX SMALL EXTERNAL FIXATION SYSTEM, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K131413 · Zimmer, Inc. · Orthopedic device
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Jan 2014
Decision
257d
Days
Class 2
Risk

K131413 is an FDA 510(k) clearance for the XTRAFIX SMALL EXTERNAL FIXATION SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 28, 2014 after a review of 257 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K131413

510(k) Number K131413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2013
Decision Date January 28, 2014
Days to Decision 257 days
Submission Type Traditional
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
135d slower than avg
Panel avg: 122d · This submission: 257d
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 361
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K131413.
EMERGE EXTERNAL FIXATION SYSTEM
K140675 · Emerge Medical, Inc. · Jun 2014
S.E.A.L. FRACTURE FUSION TUBE
K140158 · Dne, LLC · May 2014
DRIVE RAIL SYSTEM
K140822 · Devise Ortho, Inc. · May 2014
DOLPHIX EXTERNAL FIXATION SYSTEM
K132363 · Citieffe S.R.L. · Jan 2014
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K130907 · Stryker Trauma AG · Jun 2013
NBX - NON BRIDGING EXTERNAL FIXATOR HAND
K122777 · Nutek Orthopaedics, Inc. · May 2013