# K073420: Blackstone Ascent Multiaxial Screws

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Feb 14, 2008 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: 12 generations back to K003155 (2001). 84 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 94 devices in its family (counting itself) have 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.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 1.
- K062853: Modification to Stryker Spine Oasys System, Stryker Spine (2006) Summary page 1.
- K070742: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2007) Summary page 1.

## Most influential descendants
- K161032: neon3™  universal OCT spinal stabilization (2016), 7 descendants of its own
- K191932: Momentum™ Posterior Spinal Fixation System (2019), 2 descendants of its own
- K231809: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (2023), 1 descendant of its own
- K113346: Neon System (2012), 1 descendant of its own
- K251719: Momentum® Posterior Spinal Fixation System (2025), 0 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 (TI-T3). The hooks are intended to be placed from CI 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 Connector.

Source page: https://510kreport.com/device/K073420
Methodology: https://510kreport.com/methodology