Cleared Traditional

K092190 - SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS

K092190 is an FDA 510(k) clearance for SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K092190 · Synthes (Usa) · Orthopedic device
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May 2010
Decision
294d
Days
Class 2
Risk

K092190 is an FDA 510(k) clearance for the SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICAT.... 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 May 11, 2010 after a review of 294 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K092190

510(k) Number K092190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2009
Decision Date May 11, 2010
Days to Decision 294 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
172d slower than avg
Panel avg: 122d · This submission: 294d
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 358
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K092190.
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SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES
K100137 · Wrightmedicaltechnologyinc · Jun 2010
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
K090658 · Synthes (Usa) · Mar 2010
MINI RAIL EXTERNAL FIXATOR SYSTEM
K093550 · Small Bone Innovations, Inc. · Jan 2010
AFGHAN EXTERNAL FIXATOR
K092002 · Smith & Nephew, Inc. · Dec 2009