# K040034: Blackstone Ascent Poct System Lateral Offset Adapter

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Feb 11, 2004 after 34 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
No predicates in its family tree.
139 later devices descend from it; 3 cite it directly.
1 of 140 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K040034
Methodology: https://510kreport.com/methodology