Cleared Traditional

K771109 - ORTHOPEDIC SOFT GOODS (FDA 510(k) Clearance)

Class I Physical Medicine device.

K771109 · Orthopedic Systems, Inc. · Physical Medicine device
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Jun 1977
Decision
7d
Days
Class 1
Risk

K771109 is an FDA 510(k) clearance for the ORTHOPEDIC SOFT GOODS. Classified as Halter, Head, Traction (product code HSS), Class I - General Controls.

Submitted by Orthopedic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1977 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 888.5890 - 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 Orthopedic Systems, Inc. devices

Submission Details

510(k) Number K771109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1977
Decision Date June 27, 1977
Days to Decision 7 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
108d faster than avg
Panel avg: 115d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HSS Halter, Head, Traction
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5890
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.