Cleared Traditional

K904973 - EXTERNAL FIXATION

K904973 is an FDA 510(k) clearance for EXTERNAL FIXATION, manufactured by Dynasplint Systems, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K904973 · Dynasplint Systems, Inc. · Orthopedic device
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Feb 1991
Decision
115d
Days
Class 2
Risk

K904973 is an FDA 510(k) clearance for the EXTERNAL FIXATION. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Dynasplint Systems, Inc. (Baltimore, US). The FDA issued a Cleared decision on February 21, 1991 after a review of 115 days - within the typical 510(k) review window.

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 Dynasplint Systems, Inc. devices

FDA 510(k) Submission Details - K904973

510(k) Number K904973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1990
Decision Date February 21, 1991
Days to Decision 115 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 122d · This submission: 115d
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 367
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K904973.
TRAUMAFIX (TM) EXTERNAL FIXATOR
K914558 · Synthes (Usa) · Jan 1992
INTRAMEDULLARY HIP SCREW, MODIFICATION
K912162 · Smith & Nephew Richards, Inc. · Aug 1991
AUTOGENESIS(TM) AUTOMATOR
K905514 · Advanced Biosearch Assn. · Apr 1991
SIDE PLATE
K905338 · O'Tec Corp. · Dec 1990
LAG SCREW
K905342 · O'Tec Corp. · Dec 1990
JEWETT HIP NAIL
K905346 · O'Tec Corp. · Dec 1990