Cleared Traditional

K924455 - SYNTHES (USA) TITANIUM LOCKED SPIKED WA...

K924455 is the FDA 510(k) clearance for SYNTHES (USA) TITANIUM LOCKED SPIKED WA... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HTN) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K924455 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 1993
Decision
252d
Days
Class 2
Risk

K924455 is an FDA 510(k) clearance for the SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 12, 1993 after a review of 252 days - an extended review 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: 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 Synthes (Usa) devices

Submission Details

510(k) Number K924455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1992
Decision Date May 12, 1993
Days to Decision 252 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
130d slower than avg
Panel avg: 122d · This submission: 252d
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 65
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K924455.
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
SPIKED WASHER
K914472 · Synthes (Usa) · Nov 1991
T-BOLT AND NUT
K911306 · Danek Medical, Inc. · Sep 1991
WYMAN SUTURE WASHER
K910186 · Acu Med, Inc. · Jul 1991