Cleared Traditional

K811456 - ORTHO-FRAC KIT

K811456 is an FDA 510(k) clearance for ORTHO-FRAC KIT, manufactured by Orthomedics. The device is a Class 1 Physical Medicine device with product code IQI cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K811456 · Orthomedics · Physical Medicine device
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Jun 1981
Decision
21d
Days
Class 1
Risk

K811456 is an FDA 510(k) clearance for the ORTHO-FRAC KIT. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Orthomedics (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - the FDA physical medicine device 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 Orthomedics devices

FDA 510(k) Submission Details - K811456

510(k) Number K811456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1981
Decision Date June 12, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

IQI Device Classification - Class 1, General Controls

Product Code IQI Orthosis, Limb Brace
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
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 - IQI Orthosis, Limb Brace

All 24
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K811456.
ROTATION BOOT
K823160 · Warm & Form, Orthopedic Materials · Nov 1982
ORTHOTIC FABRICATION ACCESSORIES
K821640 · Fred Sammons, Inc. · Jun 1982
OBTHOSES
K821641 · Fred Sammons, Inc. · Jun 1982
FOREARM & KNEE STRAPS
K811490 · Fred Sammons, Inc. · Jun 1981
HUMERAL FRACTURE CAST BRACE
K811343 · Deseret Medical, Inc. · May 1981
LIMB ORTHOSIS
K810443 · Fred Sammons, Inc. · Mar 1981