Cleared Traditional

K070724 - IOS EXTERNAL FIXATOR, MODEL 2-0-0

K070724 is an FDA 510(k) clearance for IOS EXTERNAL FIXATOR, manufactured by Intelligent Orthopaedics, Ltd.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K070724 · Intelligent Orthopaedics, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
62d
Days
Class 2
Risk

K070724 is an FDA 510(k) clearance for the IOS EXTERNAL FIXATOR, MODEL 2-0-0. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Intelligent Orthopaedics, Ltd. (Brierfield, Nelson, GB). The FDA issued a Cleared decision on May 16, 2007 after a review of 62 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 Intelligent Orthopaedics, Ltd. devices

FDA 510(k) Submission Details - K070724

510(k) Number K070724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2007
Decision Date May 16, 2007
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
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 316
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K070724.
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