Cleared Traditional

FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) (K031401) - FDA 510(k) Clearance

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

K031401 · Disco-O-Tech Medical Technologies, Ltd. · Orthopedic device
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Aug 2003
Decision
93d
Days
Class 2
Risk

K031401 is an FDA 510(k) clearance for the FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS). Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Disco-O-Tech Medical Technologies, Ltd. (Herzlia, IL). The FDA issued a Cleared decision on August 6, 2003 after a review of 93 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 Disco-O-Tech Medical Technologies, Ltd. devices

Submission Details

510(k) Number K031401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2003
Decision Date August 06, 2003
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K031401.
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
K033556 · Synthes (Usa) · Jan 2004
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS
K033411 · Synthes (Usa) · Nov 2003
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
K033158 · Synthes (Usa) · Nov 2003
EXTERNAL FIXATION SYSTEMS
K031181 · Smith & Nephew, Inc. · Jul 2003
SYNTHES SMALL COBINATION CLAMP-MR SAFE
K031724 · Synthes (Usa) · Jul 2003
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
K031725 · Synthes (Usa) · Jun 2003