# K153042: TRYPTIK2C-plate Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Mar 28, 2016 after 161 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922087 (1992). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072650: Ist Anterior Cervical Plate System, Innovative Spinal Technologies, Inc. (2007) Summary page 4.
- K792352: Synthes Cervical Vertabrae Plates, DePuy Synthes (1979) Summary page 4.
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 4.
- K043082: The Tosca Anterior Cervical Plate System, Signus Medizintechnik GmbH (2004) Summary page 4.
- K052292: Spider Cervical Plating (SCP) System, X-Spine Systems, Inc. (2005) Summary page 4.

## Most influential descendants
- K171797: TRYPTIK2 C-Plate Anterior Cervical Plate System (2018), 0 descendants of its own

## Recalls of this device
- Nov 27, 2017 · Class II · Z-0336-2018: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
- Nov 27, 2017 · Class II · Z-0337-2018: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
- Nov 27, 2017 · Class II · Z-0338-2018: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
- Nov 27, 2017 · Class II · Z-0339-2018: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
- Nov 27, 2017 · Class II · Z-0340-2018: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
- Nov 27, 2017 · Class II · Z-0341-2018: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
- Nov 27, 2017 · Class II · Z-0342-2018: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.

## 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/K153042
Methodology: https://510kreport.com/methodology