Cleared Traditional

K843121 - GUIDE TO THE KNEE

K843121 is an FDA 510(k) clearance for GUIDE TO THE KNEE, manufactured by Dyonics, Inc.. The device is a Class 1 General & Plastic Surgery device with product code BWN cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K843121 · Dyonics, Inc. · General & Plastic Surgery device
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Sep 1984
Decision
30d
Days
Class 1
Risk

K843121 is an FDA 510(k) clearance for the GUIDE TO THE KNEE. Classified as Table And Attachments, Operating-room (product code BWN), Class I - General Controls.

Submitted by Dyonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - the FDA general and plastic surgery 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 Dyonics, Inc. devices

FDA 510(k) Submission Details - K843121

510(k) Number K843121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1984
Decision Date September 07, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

BWN Device Classification - Class 1, General Controls

Product Code BWN Table And Attachments, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
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 - BWN Table And Attachments, Operating-room

Devices cleared under the same product code (BWN) and FDA review panel - the closest regulatory comparables to K843121.
BAUMER SURGICAL TABLE
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