Cleared Traditional

K090658 - SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL

K090658 is an FDA 510(k) clearance for SYNTHES EXTERNAL FIXATION DEVICES, 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 356-day FDA review.

K090658 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
356d
Days
Class 2
Risk

K090658 is an FDA 510(k) clearance for the SYNTHES EXTERNAL FIXATION DEVICES, 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 March 3, 2010 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K090658

510(k) Number K090658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2009
Decision Date March 03, 2010
Days to Decision 356 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
234d slower than avg
Panel avg: 122d · This submission: 356d
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 K090658.
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
K100795 · Smith & Nephew, Inc. · Sep 2010
SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES
K100137 · Wrightmedicaltechnologyinc · Jun 2010
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
K092190 · Synthes (Usa) · May 2010
MINI RAIL EXTERNAL FIXATOR SYSTEM
K093550 · Small Bone Innovations, Inc. · Jan 2010
AFGHAN EXTERNAL FIXATOR
K092002 · Smith & Nephew, Inc. · Dec 2009
BIOMET VISION FOOTRING SYSTEM
K093057 · Ebi, L.P. · Dec 2009