Cleared Traditional

SOFT TISSUE SUTURE WASHER (K991135) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K991135 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
24d
Days
Class 2
Risk

K991135 is an FDA 510(k) clearance for the SOFT TISSUE SUTURE WASHER. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 29, 1999 after a review of 24 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, Inc. devices

Submission Details

510(k) Number K991135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1999
Decision Date April 29, 1999
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 50
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K991135.
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
K023119 · Arthrex, Inc. · Dec 2002
SYNTHES METALLIC SPIKED WASHERS
K013806 · Synthes (Usa) · Feb 2002
SPIKED WASHER
K011583 · Synthes (Usa) · Jan 2002
DEPUY ORTHOTECH SPIKED WASHER
K983906 · DePuy Orthopaedics, Inc. · Dec 1998
SYNTHES SCHUHLI IMPLANT SYSTEM
K980944 · Synthes (Usa) · Apr 1998
SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER
K924455 · Synthes (Usa) · May 1993