# K080646: C-Tek Maxan Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: May 2, 2008 after 57 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953730 (1995). 8 ancestors in all.
193 later devices descend from it; 11 cite it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060379: Ebi Anterior Cervical Plate System, Ebi, L.P. (2006) Summary page 1.
- K070994: Eagle + Anterior Cervical Plate System, Depuy Spine, Inc. (2007) Summary page 1.
- K040197: Eagle Anterior Cervial Plate System, Depuyacromed (2004) Summary page 1.
- K072546: Swift Plus Anterior Cervical Plate System, Depuy Spine, Inc. (2007) Summary page 1.
- K040655: Swift Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 1.

## Most influential descendants
- K133475: Struxxure Anterior Cervical Plate and Screws (2013), 132 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 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.
- Aug 5, 2015 · Class II · Z-2744-2015: Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.

## Indications for use
The C-Tek® MaxAnTM 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/K080646
Methodology: https://510kreport.com/methodology