# K982443: Doc Ventral Cervical Stabilization System

- Pathway: 510(k) (Special)
- Applicant: Depuy Motech Acromed
- Decided: Jul 29, 1998 after 15 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 K970462 (1997). 2 ancestors in all.
71 later devices descend from it; 7 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970955: Acromed Anterior Cervical Stabilization System, Acromed Corp. (1997) Summary page 4.
- K970462: Acromed Anterior Cervical Stabilization System, Acromed Corp. (1997) Summary page 4.

## Most influential descendants
- K043066: Pioneer Anterior Cervical Plate System (2005), 27 descendants of its own
- K053053: Pacp System (2005), 25 descendants of its own
- K121514: Anodyne Anterior Cervical Plate System (2012), 21 descendants of its own
- K072703: Pioneer Slimfuse Anterior Cervical Plating System (2008), 19 descendants of its own
- K163104: Terrace™ Anterior Cervical Plate System (2017), 18 descendants of its own

## Indications for use
The AcroMed DOC™ Ventral Cervical Stabilization System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in whom stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma (including fracture), post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies). re-operation for failed fusion, or instability following surgery for the above indications.

Source page: https://510kreport.com/device/K982443
Methodology: https://510kreport.com/methodology