Cleared Special

K012305 - MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM

K012305 is an FDA 510(k) clearance for MODIFICATION TO: TRINICA ANTERIOR CERVI..., manufactured by Sulzer Spine-Tech. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 30-day FDA review.

K012305 · Sulzer Spine-Tech · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
30d
Days
Class 2
Risk

K012305 is an FDA 510(k) clearance for the MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Sulzer Spine-Tech (Minneapolis, US). The FDA issued a Cleared decision on August 22, 2001 after a review of 30 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 Sulzer Spine-Tech devices

FDA 510(k) Submission Details - K012305

510(k) Number K012305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2001
Decision Date August 22, 2001
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 560
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K012305.
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
K013558 · Blackstone Medical, Inc. · Jan 2002
CODMAN SLIM-LOC SYSTEM
K013877 · Codman & Shurtleff, Inc. · Dec 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · Aesculap, Inc. · Nov 2001
MACROPORE OS SPINAL SYSTEM
K010911 · Macropore Biosurgery, Inc. · Jul 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824 · Aesculap, Inc. · May 2001
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K010115 · Howmedica Osteonics Corp. · Apr 2001