Cleared Traditional

K963420 - CANCELLOUS SCREW WASHER

K963420 is the FDA 510(k) clearance for CANCELLOUS SCREW WASHER by Orthopaedic Biosystems, Ltd.. It is a Class 2 Orthopedic device (product code HTN) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K963420 · Orthopaedic Biosystems, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
77d
Days
Class 2
Risk

K963420 is an FDA 510(k) clearance for the CANCELLOUS SCREW WASHER. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Orthopaedic Biosystems, Ltd. (Scotsdale, US). The FDA issued a Cleared decision on November 15, 1996 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: 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 Orthopaedic Biosystems, Ltd. devices

Submission Details

510(k) Number K963420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1996
Decision Date November 15, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTN Washer, Bolt Nut
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HTN Washer, Bolt Nut

All 66
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K963420.
DEPUY ORTHOTECH SPIKED WASHER
K983906 · DePuy Orthopaedics, Inc. · Dec 1998
SYNTHES SCHUHLI IMPLANT SYSTEM
K980944 · Synthes (Usa) · Apr 1998
ACUMED SUTURE WASHER
K965028 · Acu Med, Inc. · Mar 1997
WASHER, BOLT, NUT, ORTHOPEDIC
K954682 · Linvatec Corp. · Feb 1996
SUTURE WASHER
K954148 · Acu Med, Inc. · Jan 1996
BONE SCREW WASHER
K943782 · Acu Med, Inc. · Dec 1994