Cleared Traditional

K082650 - SYNTHES LARGE EXTERNAL FIXATION

K082650 is the FDA 510(k) clearance for SYNTHES LARGE EXTERNAL FIXATION by Synthes (Usa). It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K082650 · Synthes (Usa) · Orthopedic device
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Nov 2008
Decision
67d
Days
Class 2
Risk

K082650 is an FDA 510(k) clearance for the SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on November 18, 2008 after a review of 67 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 Synthes (Usa) devices

Submission Details

510(k) Number K082650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2008
Decision Date November 18, 2008
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 275
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K082650.
SMITH & NEPHEW RAIL SYSTEM
K090926 · Smith & Nephew, Inc. · Jun 2009
ACE FISCHER EXTERNAL FIXATION SYSTEM
K083789 · DePuy Orthopaedics, Inc. · Mar 2009
REPROCESSED EXTERNAL FIXATION DEVICE
K083636 · Sterilmed, Inc. · Mar 2009
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