# K970806: Acpii Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: May 2, 1997 after 58 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
No predicates in its family tree.
36 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081038: Atlantis Anterior Cervical Plate System (2008), 35 descendants of its own
- K130640: Atlantis Anterior Cervical Plate System (2013), 32 descendants of its own
- K141632: Zevo (TM) Anterior Cervical Plate System (2014), 18 descendants of its own
- K141599: Divergence Anterior Cervical Fusion System (2015), 16 descendants of its own
- K140417: Divergence Mini-Plate Anterior Cervical Fusion System (2014), 11 descendants of its own

## Indications for use
The ACPii Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with 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, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Source page: https://510kreport.com/device/K970806
Methodology: https://510kreport.com/methodology