Cleared Traditional

K901272 - ORION BLADE PLATE FOR TIBIAL OSTEOTOMY

K901272 is an FDA 510(k) clearance for ORION BLADE PLATE FOR TIBIAL OSTEOTOMY, manufactured by Med-Tek Corp.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K901272 · Med-Tek Corp. · Orthopedic device
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Apr 1990
Decision
35d
Days
Class 2
Risk

K901272 is an FDA 510(k) clearance for the ORION BLADE PLATE FOR TIBIAL OSTEOTOMY. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Med-Tek Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 23, 1990 after a review of 35 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 Med-Tek Corp. devices

FDA 510(k) Submission Details - K901272

510(k) Number K901272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1990
Decision Date April 23, 1990
Days to Decision 35 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 122d · This submission: 35d
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 369
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K901272.
SIDE PLATE
K903246 · Onyx Medical Corp. · Jul 1990
BLADE PLATE
K903250 · Onyx Medical Corp. · Jul 1990
JEWETT HIP NAIL
K903251 · Onyx Medical Corp. · Jul 1990
ALTA LAG SCREW AND COMPRESSION SCREW
K900584 · Howmedica Corp. · Apr 1990
DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR
K890989 · Origin Medsystems, Inc. · Apr 1990
LINK GIEBEL BLADE PLATE SYSTEM
K895507 · Link America, Inc. · Mar 1990