Cleared Traditional

SALVATION External Fixation System (K150004) - FDA 510(k) Clearance

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

K150004 · Wrightmedicaltechnologyinc · Orthopedic device
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Mar 2015
Decision
61d
Days
Class 2
Risk

K150004 is an FDA 510(k) clearance for the SALVATION External Fixation System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on March 4, 2015 after a review of 61 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K150004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2015
Decision Date March 04, 2015
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
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 174
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K150004.
FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control
K151992 · Zimmer, Inc. · Nov 2015
SALVATION® External Fixation System
K152045 · Wrightmedicaltechnologyinc · Aug 2015
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
K150818 · Zimmer, Inc. · May 2015
SIDEKICK EZ FRAME External Fixation System
K143220 · Wrightmedicaltechnologyinc · Jan 2015
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
K142520 · Smith & Nephew, Inc. · Nov 2014
XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K141697 · Zimmer, Inc. · Sep 2014