# K213443: Insignia™ Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Dec 15, 2021 after 51 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: 7 generations back to K953730 (1995). 28 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200995: Insignia™ Anterior Cervical Plate System, Alphatec Spine, Inc. (2020) Summary page 4.

## Most influential descendants
- K233640: Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System (2024), 5 descendants of its own
- K241375: IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer (2025), 3 descendants of its own
- K251575: IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System (2025), 0 descendants of its own
- K251965: Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (2025), 0 descendants of its own
- K252113: PRADO™ Lumbar Interbody Fusion System (2025), 0 descendants of its own

## Indications for use
The Insignia™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) 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), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

Source page: https://510kreport.com/device/K213443
Methodology: https://510kreport.com/methodology