Cleared Traditional

K823395 - TRACTION-STEEL FRAMING SYSTEM

K823395 is an FDA 510(k) clearance for TRACTION-STEEL FRAMING SYSTEM, manufactured by Orthopedic Systems, Inc.. The device is a Class 1 Neurology device with product code HST cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K823395 · Orthopedic Systems, Inc. · Neurology device
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Dec 1982
Decision
21d
Days
Class 1
Risk

K823395 is an FDA 510(k) clearance for the TRACTION-STEEL FRAMING SYSTEM. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Orthopedic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.5850 - the FDA neurology 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

FDA 510(k) Submission Details - K823395

510(k) Number K823395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1982
Decision Date December 03, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 148d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

HST Device Classification - Class 1, General Controls

Product Code HST Apparatus, Traction, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5850
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 - HST Apparatus, Traction, Non-powered

All 13
Devices cleared under the same product code (HST) and FDA review panel - the closest regulatory comparables to K823395.
ACUFEX SHOULDER HOLDER
K841388 · Acufex Microsurgical, Inc. · May 1984
TRACTION ACCESSORIES
K823813 · Danek Medical, Inc. · Jan 1983
OCTAGONAL ALUMINUM FRAMING SYSTEM
K823372 · Orthopedic Systems, Inc. · Dec 1982
FOREARM REDUCTION UNIT
K823392 · Orthopedic Systems, Inc. · Nov 1982
TENSOPLAST SKIN TRACTION KIT
K820612 · Smith & Nephew, Inc. · Mar 1982
UPPER EXTREMITY TRACTION DEVICE
K803021 · Orthopedic Systems, Inc. · Dec 1980