# K171797: TRYPTIK2 C-Plate Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Feb 26, 2018 after 255 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: 4 generations back to K922087 (1992). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153042: TRYPTIK2C-plate Anterior Cervical Plate System, Spineart (2016) Summary page 4.
- K100265: Diamond Anterior Cervical Plate System, Amendia, Inc. (2010) Summary page 4.
- K052292: Spider Cervical Plating (SCP) System, X-Spine Systems, Inc. (2005) Summary page 4.
- K050451: Synthes Vectra System, Synthes Spine Co.Lp (2005) Summary page 4.

## Indications for use
TRYPTIK2C-Plate® Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions

Source page: https://510kreport.com/device/K171797
Methodology: https://510kreport.com/methodology