Cleared Traditional

K965028 - ACUMED SUTURE WASHER

K965028 is an FDA 510(k) clearance for ACUMED SUTURE WASHER, manufactured by Acu Med, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K965028 · Acu Med, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
90d
Days
Class 2
Risk

K965028 is an FDA 510(k) clearance for the ACUMED SUTURE WASHER. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on March 17, 1997 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Acu Med, Inc. devices

FDA 510(k) Submission Details - K965028

510(k) Number K965028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1996
Decision Date March 17, 1997
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 86
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K965028.
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
K982354 · Special Devices, Inc. · Nov 1998
DEPUY ACE COMPOSITE LOCKING NUT
K983265 · Depuy Ace Medical Co. · Oct 1998
SYNTHES SCHUHLI IMPLANT SYSTEM
K980944 · Synthes (Usa) · Apr 1998
CANCELLOUS SCREW WASHER
K963420 · Orthopaedic Biosystems, Ltd. · Nov 1996
WASHER, BOLT, NUT, ORTHOPEDIC
K954682 · Linvatec Corp. · Feb 1996
SUTURE WASHER
K954148 · Acu Med, Inc. · Jan 1996