# K970955: Acromed Anterior Cervical Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Jun 11, 1997 after 86 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.
72 later devices descend from it; 1 cites it directly.
0 of 73 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 its predicate without a number.
- (no number) TOP Cervical Spine Stabilization System: named in the summary without a submission number

## Most influential descendants
- K982443: Doc Ventral Cervical Stabilization System (1998), 71 descendants of its own
- 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

## Indications for use
The AcroMed Anterior Cervical Stabilization System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which 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/K970955
Methodology: https://510kreport.com/methodology