# K003735: Blackstone Spinal Fixation System, Second-Generation Cross-Connector

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: May 8, 2001 after 155 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.
306 later devices descend from it; 8 cite it directly.
0 of 307 devices in its family (counting itself) have 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
- K022605: Blackstone Spinal Fixation System Staple & Washer (2002), 302 descendants of its own
- K022399: Blackstone Spinal Fixation System Spacer (2002), 300 descendants of its own
- K030581: Blackstone Spinal Fixation System Lateral Offset (System Modification) (2003), 298 descendants of its own
- K030862: Blackstone Spinal Fixation System Rigid Cross Connector (2003), 297 descendants of its own
- K030241: Modification to Blackstone Spinal Fixation System (2003), 297 descendants of its own

Source page: https://510kreport.com/device/K003735
Methodology: https://510kreport.com/methodology