Cleared Special

K022344 - TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM

K022344 is an FDA 510(k) clearance for TRINICA SELECT ANTERIOR CERVICAL PLATE ..., manufactured by Centerpulse Spine-Tech, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 67-day FDA review.

K022344 · Centerpulse Spine-Tech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
67d
Days
Class 2
Risk

K022344 is an FDA 510(k) clearance for the TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Centerpulse Spine-Tech, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 24, 2002 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Centerpulse Spine-Tech, Inc. devices

FDA 510(k) Submission Details - K022344

510(k) Number K022344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2002
Decision Date September 24, 2002
Days to Decision 67 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 540
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K022344.
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791 · Synthes (Usa) · Nov 2002
INCOMPASS SPINAL FIXATION SYSTEM
K021564 · Spinal Concepts, Inc. · Oct 2002
MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K023133 · Ebi, L.P. · Oct 2002
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K021761 · Medtronic Sofamor Danek · Sep 2002
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
K022605 · Blackstone Medical, Inc. · Aug 2002
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K022419 · Ebi, L.P. · Aug 2002