Cleared Traditional

K873722 - PEDESTAL WALKING HEEL PRODUCT NO. 4183-133

K873722 is an FDA 510(k) clearance for PEDESTAL WALKING HEEL PRODUCT NO. 4183-133, 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 17-day FDA review.

K873722 · Martin Medical · Orthopedic device
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Oct 1987
Decision
17d
Days
Class 1
Risk

K873722 is an FDA 510(k) clearance for the PEDESTAL WALKING HEEL PRODUCT NO. 4183-133. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Martin Medical (Desoto, US). The FDA issued a Cleared decision on October 2, 1987 after a review of 17 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 - K873722

510(k) Number K873722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1987
Decision Date October 02, 1987
Days to Decision 17 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 122d · This submission: 17d
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 K873722.
ARTIFLEX(TM)
K910274 · Beiersdorf, Inc. · Mar 1991
CARAGLAS XTRA SYNTHETIC CASTING TAPE
K896634 · Buckman Co., Inc. · Jun 1990
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