Cleared Traditional

K861074 - AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200

K861074 is an FDA 510(k) clearance for AMERICAN ORTHOPAEDIC CAST CUTTER, manufactured by Martin Medical. The device is a Class 1 Orthopedic device with product code LGF cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K861074 · Martin Medical · Orthopedic device
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Mar 1986
Decision
7d
Days
Class 1
Risk

K861074 is an FDA 510(k) clearance for the AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Martin Medical (Desoto, US). The FDA issued a Cleared decision on March 28, 1986 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5940 - 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 Martin Medical devices

FDA 510(k) Submission Details - K861074

510(k) Number K861074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1986
Decision Date March 28, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 122d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

LGF Device Classification - Class 1, General Controls

Product Code LGF Component, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5940
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LGF Component, Cast

All 18
Devices cleared under the same product code (LGF) and FDA review panel - the closest regulatory comparables to K861074.
SYNTHETIC CAST TAPE
K883294 · Carapace, Inc. · Aug 1988
COLORED CASTING TAPE (RED AND BLUE)
K870404 · Buckman Co., Inc. · Feb 1987
OEC DESIGN ORTHOPEDIC CAST HEEL
K864092 · Military Engineering, Inc. · Dec 1986
DELTA-LITE CASTING RESIN
K854554 · Johnson & Johnson Professionals, Inc. · Dec 1985
DELTA-LITE CASTING RESIN
K854341 · Johnson & Johnson Professionals, Inc. · Nov 1985
CAST TOE COVER
K823819 · Danek Medical, Inc. · Jan 1983