Cleared Traditional

K081244 - LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS

K081244 is an FDA 510(k) clearance for LOWER EXTREMITY EXTERNAL FIXATION - EXP..., manufactured by Biomet Trauma. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K081244 · Biomet Trauma · Orthopedic device
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Jul 2008
Decision
90d
Days
Class 2
Risk

K081244 is an FDA 510(k) clearance for the LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Biomet Trauma (Warsaw, US). The FDA issued a Cleared decision on July 30, 2008 after a review of 90 days - within the typical 510(k) review window.

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 Biomet Trauma devices

FDA 510(k) Submission Details - K081244

510(k) Number K081244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2008
Decision Date July 30, 2008
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 316
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K081244.
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
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REPROCESSED EXTERNAL FIXATION DEVICE
K081586 · Sterilmed, Inc. · Aug 2008
REPROCESSED EXTERNAL FIXATION ACCESSORIES
K081342 · Sterilmed, Inc. · Aug 2008
VARIAX DISTAL FIBULA PLATE
K081284 · Howmedica Osteonics Corp. · Jul 2008
OMEGA 3 TROCHANTERIC STABILIZING PLATE
K081278 · Howmedica Osteonics Corp. · May 2008
EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD
K080408 · Advanced Orthopaedic Solutions, Inc. · Apr 2008