Cleared Traditional

R-X-FIX EXTERNAL FIXATOR (K051017) - FDA 510(k) Clearance

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

K051017 · R-X-Fix · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
69d
Days
Class 2
Risk

K051017 is an FDA 510(k) clearance for the R-X-FIX EXTERNAL FIXATOR. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by R-X-Fix (Round Rock, US). The FDA issued a Cleared decision on June 29, 2005 after a review of 69 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-X-Fix devices

Submission Details

510(k) Number K051017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2005
Decision Date June 29, 2005
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
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 K051017.
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K052037 · Howmedica Osteonics Corp. · Aug 2005
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
K051600 · Synthes (Usa) · Jul 2005
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
K051049 · Synthes (Usa) · Jul 2005
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