# K100265: Diamond Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Amendia, Inc.
- Decided: May 13, 2010 after 104 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: 2 generations back to K792352 (1979). 6 ancestors in all.
34 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041469: Anterior Compact System, X-Spine Systems (2004) Summary page 1.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K042499: Orion Anterior Cervical Plating System, Medtronic Sofamor Danek (2004) Summary page 1.

## Most influential descendants
- K113329: K2M, Pyrenees Cervical Plate System (2012), 28 descendants of its own
- K130202: Iris Anterior Cervical Plate (2013), 21 descendants of its own
- K163104: Terrace™ Anterior Cervical Plate System (2017), 18 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS) (2021), 9 descendants of its own

## Indications for use
The Diamond Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-Tl. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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 * Deformities or curvatures (including kyphosis, lordosis, or scoliosis) * Pseudarthrosis * Failed previous fusion * Spondylolisthesis * Spinal Stenosis. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine

Source page: https://510kreport.com/device/K100265
Methodology: https://510kreport.com/methodology