# K073500: Active Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Sanacor
- Decided: Jul 3, 2008 after 203 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: 4 generations back to K922087 (1992). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062371: Preview Anterior Cervical Plate System, Alphaspine, Inc. (2006) Summary page 1.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 1.
- K982443: Doc Ventral Cervical Stabilization System, Depuy Motech Acromed (1998) Summary page 1.
- K062181: C-Jaws Cervical Compressive Mini Frame, Medicrea Technologies (2007) Summary page 1.
- K061385: Osstaple, Ossplate, Ossforce, Biomedical Enterprises, Inc. (2007) Summary page 1.
- K043066: Pioneer Anterior Cervical Plate System, Pioneer Surgical Technology (2005) Summary page 1.
- K024326: Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System, Spinal Concepts, Inc. (2003) Summary page 1.
- K051665: Synthes Vectra-T System, Synthes Spine (2005) Summary page 1.
- K012881: C3 Anterior Cervical Plate System, Spine Vision, Inc. (2001) Summary page 2.

## Indications for use
The Active TM Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The Active TM Anterior Cervical Plate System is intended for use under the following indications: · Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient 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 * Failed previous fusion

Source page: https://510kreport.com/device/K073500
Methodology: https://510kreport.com/methodology