# K042100: Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial Connector

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Sep 20, 2004 after 47 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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.
139 later devices descend from it; 3 cite it directly.
1 of 150 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
- K073654: Blackstone Ascent Poct System Parallel Rod Connector (2008), 129 descendants of its own
- 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

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone T M Ascent POCT System is indicated for: a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) b) spondylolisthesis c) spinal stenosis d) fracture/dislocation e) atlanto/axial fracture with instability f) occipitocervical dislocation g) revision of previous cervical spine surgery h) tumors 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 -3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. The Songer Cable System to be used with the Blackstone POCT 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 Connector

Source page: https://510kreport.com/device/K042100
Methodology: https://510kreport.com/methodology