Cleared Traditional

K843449 - AUTODYNAMIC COMPRESSION HIP SCREW-PLATE

K843449 is an FDA 510(k) clearance for AUTODYNAMIC COMPRESSION HIP SCREW-PLATE, manufactured by Mecron Medical Products, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K843449 · Mecron Medical Products, Inc. · Orthopedic device
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Oct 1984
Decision
47d
Days
Class 2
Risk

K843449 is an FDA 510(k) clearance for the AUTODYNAMIC COMPRESSION HIP SCREW-PLATE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Mecron Medical Products, Inc. (Port Washington, US). The FDA issued a Cleared decision on October 22, 1984 after a review of 47 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 Mecron Medical Products, Inc. devices

FDA 510(k) Submission Details - K843449

510(k) Number K843449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1984
Decision Date October 22, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 122d · This submission: 47d
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 366
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K843449.
MEC ROD CONNECTOR
K850443 · Pfizer, Inc. · Jul 1985
SUPRACONDYLAR BONE PLATE
K851919 · Warsaw Orthopedic, Inc. · Jun 1985
TROCHANTER CABLE GRIP SYSTEM
K844068 · Howmedica Corp. · Jun 1985
T.O.D. PLATE SYSTEM
K842681 · Kirschner Medical Corp. · Sep 1984
T.O.D. PLATE SYS STERILE
K842695 · Kirschner Medical Corp. · Sep 1984
ACE/FISHER EXTERNAL FIXATOR
K842768 · Buckman Co., Inc. · Sep 1984