# K030197: Blackstone Posterior Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Jun 12, 2003 after 142 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K853033 (1985). 9 ancestors in all.
193 later devices descend from it; 12 cite it directly.
1 of 203 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002733: Summit Occipito-Cervico-Thoracic (Oct) Spinal System, Depuyacromed (2000) Summary page 1.

## Most influential descendants
- K042100: Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial Connector (2004), 139 descendants of its own
- K033980: Blackstone Ascent Poct System Hooks (System Modification) (2004), 134 descendants of its own
- 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

## Recalls of this device
- Feb 2, 2010 · Not classified · Z-1144-2010: The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium.

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the BlackstoneTM Posterior Cervical 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) atlantoaxial fracture with instability f) occipito-cervical 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-T3) 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 BlackstoneTM Posterior Cervical System allows for wire/cable attachment to the posterior cervical spine.

Source page: https://510kreport.com/device/K030197
Methodology: https://510kreport.com/methodology