# K022605: Blackstone Spinal Fixation System Staple & Washer

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Aug 21, 2002 after 15 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K980447 (1998). 6 ancestors in all.
302 later devices descend from it; 5 cite it directly.
0 of 309 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994217: Blackstone Spinal Fixation System, Blackstone Medical, Inc. (2000) Summary page 1.
- K003735: Blackstone Spinal Fixation System, Second-Generation Cross-Connector, Blackstone Medical, Inc. (2001) Summary page 1.
- K013558: Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw, Blackstone Medical, Inc. (2002) Summary page 1.
- K020674: Blackstone Spinal Fixation System 4.5MM Multi-Axial Screw, Blackstone Medical, Inc. (2002) Summary page 3.

## Most influential descendants
- K030581: Blackstone Spinal Fixation System Lateral Offset (System Modification) (2003), 298 descendants of its own
- K030241: Modification to Blackstone Spinal Fixation System (2003), 297 descendants of its own
- K080407: Blackstone SFS Parallel Rod Connectors (2008), 296 descendants of its own
- K081684: Blackstone Pedicle Screw System (2008), 277 descendants of its own
- K082797: Blackstone Pedicle Screw System (2008), 209 descendants of its own

## Indications for use
Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for anterolateral screwhtaple fixation of the T6-L5 spine, is intended for the following indications: a) Degenerative disc disease (ddd) - this should be defined. Based on the 5/23/96 Panel meeting, ddd should be defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. b) Spondylolisthesis c) Trauma (i.e., fracture or dislocation) d) Spinal stenosis; e) Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) Q Tumor g) Pseudarthrosis h) Previous failed fusion.

Source page: https://510kreport.com/device/K022605
Methodology: https://510kreport.com/methodology