# K061002: Maxima Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corp.
- Decided: Nov 15, 2006 after 218 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: 1 generation back to K994239 (2000). 2 ancestors in all.
44 later devices descend from it; 6 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.
- K030327: Zephir Anterior Cervical System, Medtronic Sofamor Danek (2003) Summary page 1.

## Most influential descendants
- K113509: Lexus Anterior Cervical Plate System (2012), 19 descendants of its own
- K143271: CastleLoc-P Anterior Cervical Plate System (2015), 15 descendants of its own
- K190425: CastleLoc-P Anterior Cervical Plate System (2019), 13 descendants of its own
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (2021), 10 descendants of its own
- K131200: Aspiron Acp System (2013), 7 descendants of its own

## Indications for use
The MaximaTM Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, 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/K061002
Methodology: https://510kreport.com/methodology