Cleared Traditional

K991931 - CTD MARK I TRACTION DEVICE

K991931 is an FDA 510(k) clearance for CTD MARK I TRACTION DEVICE, manufactured by Therasys, Inc.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K991931 · Therasys, Inc. · Physical Medicine device
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Aug 1999
Decision
65d
Days
Class 2
Risk

K991931 is an FDA 510(k) clearance for the CTD MARK I TRACTION DEVICE. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Therasys, Inc. (Moraine, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - the FDA physical medicine device 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 Therasys, Inc. devices

FDA 510(k) Submission Details - K991931

510(k) Number K991931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1999
Decision Date August 12, 1999
Days to Decision 65 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITH Device Classification - Class 2, Special Controls

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ITH Equipment, Traction, Powered

All 15
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K991931.
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