Cleared Traditional

K771218 - INTRA-ARTICULAR SHAVER

K771218 is an FDA 510(k) clearance for INTRA-ARTICULAR SHAVER, manufactured by Dyonics, Inc.. The device is a Class 1 Orthopedic device with product code KIJ cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K771218 · Dyonics, Inc. · Orthopedic device
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Feb 1978
Decision
211d
Days
Class 1
Risk

K771218 is an FDA 510(k) clearance for the INTRA-ARTICULAR SHAVER. Classified as Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (product code KIJ), Class I - General Controls.

Submitted by Dyonics, Inc. (Walker, US). The FDA issued a Cleared decision on February 1, 1978 after a review of 211 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Dyonics, Inc. devices

FDA 510(k) Submission Details - K771218

510(k) Number K771218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1977
Decision Date February 01, 1978
Days to Decision 211 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 122d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

KIJ Device Classification - Class 1, General Controls

Product Code KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.