# K953978: Anterior Dynamized System

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Feb 19, 1997 after 546 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Dwyer Spinal Instrumentation: named in the summary without a submission number
- (no number) Kaneda Anterior System: named in the summary without a submission number
- (no number) ISOLA Anterior System: named in the summary without a submission number

## Most influential descendants
- K192281: AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System (2019), 0 descendants of its own

## Indications for use
The Anterior Dynamized system is intended for use in anterior decompression instrumentation and fusion for kyphotic deformities, post traumatic kyphotic deformities, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), burst fractures, tumors and previous failed surgery of the spine. The intended levels for treatment range from T10 to L3.

Source page: https://510kreport.com/device/K953978
Methodology: https://510kreport.com/methodology