Cleared Traditional

K051049 - SYNTHES (USA) LOW-PROFILE WRIST FIXATOR

K051049 is an FDA 510(k) clearance for SYNTHES (USA) LOW-PROFILE WRIST FIXATOR, 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 79-day FDA review.

K051049 · Synthes (Usa) · Orthopedic device
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Jul 2005
Decision
79d
Days
Class 2
Risk

K051049 is an FDA 510(k) clearance for the SYNTHES (USA) LOW-PROFILE WRIST FIXATOR. 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 July 13, 2005 after a review of 79 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

FDA 510(k) Submission Details - K051049

510(k) Number K051049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2005
Decision Date July 13, 2005
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
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 K051049.
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
K051600 · Synthes (Usa) · Jul 2005
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K051180 · Vanguard Medical Concepts, Inc. · Jul 2005
GENEROS SB SMALL BONE DISTRACTION IMPLANT
K051162 · Orthonetx, Inc. · Jul 2005
R-X-FIX EXTERNAL FIXATOR
K051017 · R-X-Fix · Jun 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K051554 · Alliance Medical Corp. · Jun 2005
HA COATED LAG SCREW
K050849 · Smith & Nephew, Inc. · May 2005