Cleared Traditional

K173883 - External Fixation System

K173883 is the FDA 510(k) clearance for External Fixation System by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K173883 · Life Spine, Inc. · Orthopedic device
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Sep 2018
Decision
260d
Days
Class 2
Risk

K173883 is an FDA 510(k) clearance for the External Fixation System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on September 7, 2018 after a review of 260 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Life Spine, Inc. devices

Submission Details

510(k) Number K173883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2017
Decision Date September 07, 2018
Days to Decision 260 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
138d slower than avg
Panel avg: 122d · This submission: 260d
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 278
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K173883.
Austin Miller Large External Fixation System
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K182968 · Stryker GmbH · Jan 2019
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Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices
K180580 · Surgical Instrument Service and Savings, Inc. · Jul 2018
SALVATION External Fixation System
K180832 · Wrightmedicaltechnologyinc · Jun 2018
DePuy Synthes Femoral Neck System
K172872 · DePuy Synthes · Mar 2018