# K022344: Trinica Select Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Centerpulse Spine-Tech, Inc.
- Decided: Sep 24, 2002 after 67 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K926453 (1993). 6 ancestors in all.
43 later devices descend from it; 6 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012305: Modification to: Trinica Anterior Cervical Plate System, Sulzer Spine-Tech (2001)
- K974435: Michelson Anterior Cervical Plate System, Wrightmedicaltechnologyinc (1998) Summary page 1.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 1.
- K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1997) Summary page 1.
- K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.

## Most influential descendants
- K132012: Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate System (2013), 22 descendants of its own
- K111796: Invizia Anterior Cervical Plate System (2011), 18 descendants of its own
- K143626: inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System (2015), 16 descendants of its own
- K192481: AccelFix Lumbar Plate System (2020), 13 descendants of its own
- K040003: Vertebron SCP Cervical Plate System (2004), 12 descendants of its own

## Recalls of this device
- May 21, 2004 · Not classified · Z-1014-04: The recalled bone taps could break inside the vertebral body during the tapping process.

## Indications for use
The Trinica Select™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K022344
Methodology: https://510kreport.com/methodology