# K133518: Maxan Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine (Aka Ebi, LLC)
- Decided: Nov 5, 2014 after 355 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953730 (1995). 9 ancestors in all.
25 later devices descend from it; 12 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)
- K080646: C-Tek Maxan Anterior Cervical Plate System, Biomet Spine (2008) Summary page 4.

## Most influential descendants
- K200995: Insignia™ Anterior Cervical Plate System (2020), 7 descendants of its own
- K213443: Insignia™ Anterior Cervical Plate System (2021), 6 descendants of its own
- 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
- K162638: CETRA Anterior Cervical Plate System (2016), 3 descendants of its own

## Recalls of this device
- Sep 29, 2015 · Class II · Z-0203-2016: The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.

## Indications for use
The MaxAn" Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2-T1.

Source page: https://510kreport.com/device/K133518
Methodology: https://510kreport.com/methodology