Cleared Traditional

K780225 - ORTHOSISES DEVICES

K780225 is the FDA 510(k) clearance for ORTHOSISES DEVICES by Biomet, Inc.. It is a Class 1 Physical Medicine device (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.

View all Biomet, Inc. devices

Submission Details

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
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 18
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K780225.
SECUTEX ANKLE BAND
K791267 · Conphar, Inc. · Jul 1979
CAST BRACE COMPONENTS
K791057 · 3M Company · Jun 1979
FOOT POSITIONER
K781206 · Fred Sammons, Inc. · Jul 1978
BRACE, TENNIS ELBOW
K780053 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1978
DEVON KNEE STRAP
K760950 · Devon Industries, Inc. · Nov 1976
KNEE AID
K760002 · Zimmer, Inc. · Jul 1976