# K161524: Tangis Anterior Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, LLC
- Decided: Sep 2, 2016 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: 6 generations back to K953730 (1995). 33 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151553: Anterior Cervical Plate System, Osteomed Implantes, Ltda (2016) Summary page 5.
- K031276: Synthes Anterior Cervical Locking Plate (Aclp) System, Synthes (Usa) (2003) Summary page 5.
- K022965: Blackstone Classic Anterior Cervical Plate, Blackstone Medical, Inc. (2003) Summary page 5.

## Most influential descendants
- K210424: Quantum Anterior Cervical Plate (2021), 4 descendants of its own
- K252611: aprevo® cervical plating system (2025), 3 descendants of its own
- K260570: corra™ cervical plating system (2026), 1 descendant of its own
- K202657: Javelin Tailor's Bunion Fixation System (2020), 1 descendant of its own
- K262149: corra® cervical plating system (2026), 0 descendants of its own

## Indications for use
The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis

Source page: https://510kreport.com/device/K161524
Methodology: https://510kreport.com/methodology