Cleared Traditional

STEALTH FUSION SYSTEM, MODEL RR 1000 (K043174) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043174 · R&R Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
83d
Days
Class 2
Risk

K043174 is an FDA 510(k) clearance for the STEALTH FUSION SYSTEM, MODEL RR 1000. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by R&R Medical, Inc. (Round Rock, US). The FDA issued a Cleared decision on February 7, 2005 after a review of 83 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 R&R Medical, Inc. devices

Submission Details

510(k) Number K043174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2004
Decision Date February 07, 2005
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K043174.
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HA COATED LAG SCREW
K050849 · Smith & Nephew, Inc. · May 2005
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM
K050048 · Howmedica Osteonics Corp. · Mar 2005
TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
K043113 · DePuy Orthopaedics, Inc. · Jan 2005
SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
K043039 · Synthes (Usa) · Jan 2005
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
K042761 · Zimmer, Inc. · Nov 2004