Cleared Traditional

K894228 - KRONNER SPHERICAL CUTTERS (FDA 510(k) Clearance)

Class I Orthopedic device.

K894228 · Kronner Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
399d
Days
Class 1
Risk

K894228 is an FDA 510(k) clearance for the KRONNER SPHERICAL CUTTERS. Classified as Template (product code HWT), Class I - General Controls.

Submitted by Kronner Medical (Roseburg, US). The FDA issued a Cleared decision on July 23, 1990 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4800 - 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. Elevated predicate reliance profile. 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 Kronner Medical devices

Submission Details

510(k) Number K894228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1989
Decision Date July 23, 1990
Days to Decision 399 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
277d slower than avg
Panel avg: 122d · This submission: 399d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HWT Template
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4800
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.