# K120515: Tempus Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Neurostructures, LLC
- Decided: May 23, 2012 after 92 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: 2 generations back to K974435 (1998). 3 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 1.
- K012305: Modification to: Trinica Anterior Cervical Plate System, Sulzer Spine-Tech (2001) Summary page 1.

## Most influential descendants
- K131374: Tempus (TM) Cervical Plate System (2013), 22 descendants of its own
- K142060: Transom Anterior Cervical Plate (2014), 19 descendants of its own
- K173521: SeaSpine Cabo ACP (Anterior Cervical Plate) System (2018), 15 descendants of its own
- K202064: Admiral ACP System (2020), 14 descendants of its own
- K211903: Shoreline Threaded TruProfile® Plate (2021), 7 descendants of its own

## Indications for use
The Tempus' TM Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DOD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudloarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K120515
Methodology: https://510kreport.com/methodology