# K010466: Tether Acfs

- Pathway: 510(k) (Traditional)
- Applicant: Theken Surgical,Llc
- Decided: May 16, 2001 after 89 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.
43 later devices descend from it; 6 cite it directly.
0 of 48 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.

## Most influential descendants
- K121514: Anodyne Anterior Cervical Plate System (2012), 21 descendants of its own
- K163104: Terrace™ Anterior Cervical Plate System (2017), 18 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K040003: Vertebron SCP Cervical Plate System (2004), 12 descendants of its own
- K043181: Modification to Vertebron SCP Cervical Plate System (2004), 11 descendants of its own

## Indications for use
The Tether T""ACFS is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), 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.), spondylolisthesis; and spinal stenosis. The Tether T"°ACFS is indicated for temporary stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

Source page: https://510kreport.com/device/K010466
Methodology: https://510kreport.com/methodology