Cleared Traditional

K780225 - ORTHOSISES DEVICES

K780225 is an FDA 510(k) clearance for ORTHOSISES DEVICES, manufactured by Biomet, Inc.. The device is a Class 1 Physical Medicine device with product code IQI cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K780225 · Biomet, Inc. · Physical Medicine device
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Feb 1978
Decision
15d
Days
Class 1
Risk

K780225 is an FDA 510(k) clearance for the ORTHOSISES DEVICES. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1978 after a review of 15 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.

FDA 510(k) Submission Details - K780225

510(k) Number K780225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1978
Decision Date February 24, 1978
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 116d · This submission: 15d
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 51
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K780225.
CAST BRACE COMPONENTS
K791057 · 3M Company · Jun 1979
FOOT POSITIONER
K781206 · Fred Sammons, Inc. · Jul 1978
AIRSTIRRUP PNEUMATIC ANKLE BRACE
K780979 · Aircast, Inc. · Jun 1978
BRACE, TENNIS ELBOW
K780053 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1978
FOOT DROP BOOT
K771676 · Medical Restraints, Inc. · Sep 1977
SPLINT, BOHLER
K770612 · Will Ross Co. · Apr 1977
K780225 · ORTHOSISES DEVICES
Download PDF Biomet, Inc.