# K080394: Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Mar 13, 2008 after 29 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: 10 generations back to K853033 (1985). 20 ancestors in all.
124 later devices descend from it; 3 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.
- K040034: Blackstone Ascent Poct System Lateral Offset Adapter, Blackstone Medical, Inc. (2004) Summary page 1.
- K033980: Blackstone Ascent Poct System Hooks (System Modification), Blackstone Medical, Inc. (2004) Summary page 1.
- K042100: Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial Connector, Blackstone Medical, Inc. (2004) Summary page 1.
- K073654: Blackstone Ascent Poct System Parallel Rod Connector, Blackstone Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 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 POCT 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; f) 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 lateral offset adapter is indicated for use in the upper thoracic spine (Tl-T3). The hooks are intended to be placed from C1 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. The Blackstone Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial or ParallelRod Connector.

Source page: https://510kreport.com/device/K080394
Methodology: https://510kreport.com/methodology