# K013558: Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Jan 23, 2002 after 90 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: 1 generation back to K980447 (1998). 2 ancestors in all.
304 later devices descend from it; 6 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)
- K980447: Depuy Motech Moss Miami Spinal System, DePuy Orthopaedics, Inc. (1998). Our OCR of the scanned summary read K980477, FDA’s number for Image Vue Eeg (Sam Technology, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DePuy Motech Moss Miami Spinal System”.
- K982320: Depuy Motech Moss Miami Spinal System, Depuy, Inc. (1998) Summary page 1.

## 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
- 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

## Indications for use
Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients: a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and d) Who are having the device removed after the development of a solid fusion mass. The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: a) Degenerative spondylolisthesis with objective evidence of neurologic impairment; b) Fracture; c) Dislocation; d) Scoliosis; e) Kyphosis; f) Spinal tumor; and g) Failed previous fusion (pseudarthrosis). The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis); e) Pseudarthrosis; f) Tumor; g) Trauma (i.e., fracture or dislocation); h) Previous failed fusion.

Source page: https://510kreport.com/device/K013558
Methodology: https://510kreport.com/methodology