Cleared Traditional

K894228 - KRONNER SPHERICAL CUTTERS

K894228 is an FDA 510(k) clearance for KRONNER SPHERICAL CUTTERS, manufactured by Kronner Medical. The device is a Class 1 Orthopedic device with product code HWT cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K894228 · Kronner Medical · Orthopedic device
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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

FDA 510(k) Submission Details - K894228

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.

HWT Device Classification - Class 1, General Controls

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.

Regulatory Peers - HWT Template

All 8
Devices cleared under the same product code (HWT) and FDA review panel - the closest regulatory comparables to K894228.
ORTHOPLAN
K974406 · Ortho-Graphics, Inc. · Feb 1998
ORTHODOC PREOPERATIVE PLANNER MODEL 500
K960685 · Integrated Surgical Systems, Inc. · Jan 1997
SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA
K870843 · Warsaw Orthopedic, Inc. · May 1987
ARTHROSCOPIC MENISCAL SUTURE SYSTEM
K871323 · Orthopedic Systems, Inc. · May 1987
3M OSTEOTOMY GUIDE
K830360 · 3M Company · Mar 1983
KNEE INSTRUMENTATION, CONDYLAR
K781091 · Biomet, Inc. · Jul 1978