# K043082: The Tosca Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Nov 23, 2004 after 15 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 K922087 (1992). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990005: Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System, Spinal Concepts, Inc. (1999) Summary page 1.
- K943694: Ebi Anterior Cervical Spine System, Electro-Biology, Inc. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K020980: Dimension Tpsa Calibrator, Model #RC459, Dade Behring, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K153042: TRYPTIK2C-plate Anterior Cervical Plate System (2016), 1 descendant of its own
- K171797: TRYPTIK2 C-Plate Anterior Cervical Plate System (2018), 0 descendants of its own
- K132310: ASCOT (2013), 0 descendants of its own

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

Source page: https://510kreport.com/device/K043082
Methodology: https://510kreport.com/methodology