Cleared Traditional

K983906 - DEPUY ORTHOTECH SPIKED WASHER

K983906 is an FDA 510(k) clearance for DEPUY ORTHOTECH SPIKED WASHER, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K983906 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
45d
Days
Class 2
Risk

K983906 is an FDA 510(k) clearance for the DEPUY ORTHOTECH SPIKED WASHER. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 45 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 DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K983906

510(k) Number K983906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1998
Decision Date December 18, 1998
Days to Decision 45 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 122d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K983906.
CANNULATED SCREW SYSTEM
K003496 · Pioneer Surgical Technology · Feb 2001
HEX BUTTON
K992617 · Pioneer Surgical Technology · Oct 1999
SOFT TISSUE SUTURE WASHER
K991135 · Depuy, Inc. · Apr 1999
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