# K012305: Modification to: Trinica Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Sulzer Spine-Tech
- Decided: Aug 22, 2001 after 30 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974435 (1998). 1 ancestor in all.
70 later devices descend from it; 4 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974435: Michelson Anterior Cervical Plate System, Wrightmedicaltechnologyinc (1998) Summary page 1.

## Most influential descendants
- K022344: Trinica Select Anterior Cervical Plate System (2002), 43 descendants of its own
- K120515: Tempus Cervical Plate System (2012), 23 descendants of its own
- K132012: Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate System (2013), 22 descendants of its own
- K131374: Tempus (TM) Cervical Plate System (2013), 22 descendants of its own
- K142060: Transom Anterior Cervical Plate (2014), 19 descendants of its own

## Indications for use
The Trinica™ 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/K012305
Methodology: https://510kreport.com/methodology