# K994383: Dogbone Acfs

- Pathway: 510(k) (Traditional)
- Applicant: Theken Surgical
- Decided: Feb 4, 2000 after 38 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: 2 generations back to K926453 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970048: Synthes (Usa)Titanium Locking Plate System (Tilps), Synthes (Usa) (1997) Summary page 1.

## Indications for use
The Dogbone ACFS is indicated for trauma, deformity (tordosis and kyphosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), and spinal canal stenaosis. The Dogbone ACFS is indicated for stabilizing the spine from C2 to C7. Unicortical or bicortical fixation from the anterior face of the vertebral bodies may be employed using either the variable angle or fixed angle screws. This producl may be employed as an internal fixation device during the time interval required for arthrodesis.

Source page: https://510kreport.com/device/K994383
Methodology: https://510kreport.com/methodology