Cleared Traditional

K905342 - LAG SCREW

K905342 is an FDA 510(k) clearance for LAG SCREW, manufactured by O'Tec Corp.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K905342 · O'Tec Corp. · Orthopedic device
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Dec 1990
Decision
13d
Days
Class 2
Risk

K905342 is an FDA 510(k) clearance for the LAG SCREW. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by O'Tec Corp. (Memphis, US). The FDA issued a Cleared decision on December 11, 1990 after a review of 13 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 O'Tec Corp. devices

FDA 510(k) Submission Details - K905342

510(k) Number K905342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date December 11, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 122d · This submission: 13d
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 299
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K905342.
HOFFMANN DYNAMIC WRIST FIXATOR
K910986 · Howmedica Corp. · Jan 1992
TRAUMAFIX (TM) EXTERNAL FIXATOR
K914558 · Synthes (Usa) · Jan 1992
INTRAMEDULLARY HIP SCREW, MODIFICATION
K912162 · Smith & Nephew Richards, Inc. · Aug 1991
KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE
K901234 · Kirschner Medical Corp. · Oct 1990
SIDE PLATE
K903246 · Onyx Medical Corp. · Jul 1990
BLADE PLATE
K903250 · Onyx Medical Corp. · Jul 1990