# K033980: Blackstone Ascent Poct System Hooks (System Modification)

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Mar 3, 2004 after 71 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K853033 (1985). 10 ancestors in all.
134 later devices descend from it; 4 cite it directly.
1 of 145 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030197: Blackstone Posterior Cervical System, Blackstone Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K080394: Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System (2008), 124 descendants of its own
- K123783: Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants (2013), 97 descendants of its own
- K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS (2015), 96 descendants of its own
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (2016), 78 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone Ascent Posterior Occipital Cervical Thoracic System is indicated for: a) Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; b) Spondylolisthesis; c) Fracture/dislocation; d) Spinal stenosis; e) Atlanto-axial fracture with instability; D Occipito-cervical dislocation; g) Tumors; h) Revision of previous cervical spine surgery The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The hooks are intended to be placed from C I to T3. The Songer Cable (titanium) System to be used with the Blackstone Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine.

Source page: https://510kreport.com/device/K033980
Methodology: https://510kreport.com/methodology