# K030581: Blackstone Spinal Fixation System Lateral Offset (System Modification)

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Jun 26, 2003 after 122 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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
Longest line of descent: 3 generations back to K980447 (1998). 11 ancestors in all.
298 later devices descend from it; 3 cite it directly.
0 of 310 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.
- K020674: Blackstone Spinal Fixation System 4.5MM Multi-Axial Screw, Blackstone Medical, Inc. (2002) Summary page 1.
- K013558: Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw, Blackstone Medical, Inc. (2002) Summary page 1.
- K003735: Blackstone Spinal Fixation System, Second-Generation Cross-Connector, Blackstone Medical, Inc. (2001) Summary page 1.
- K023498: Modification to Blackstone Spinal Fixation System, Blackstone Medical, Inc. (2002) Summary page 1.
- K013885: Blackstone Spinal Fixation System Posterior Hooks, Blackstone Medical, Inc. (2002) Summary page 1.
- K022399: Blackstone Spinal Fixation System Spacer, Blackstone Medical, Inc. (2002) Summary page 1.
- K022605: Blackstone Spinal Fixation System Staple & Washer, Blackstone Medical, Inc. (2002) Summary page 1.
- (no number) Synthes device: named in the summary without a submission number
- (no number) Interpore Cross device: named in the summary without a submission number
- (no number) Surgical Dynamics device: named in the summary without a submission number

## Most influential descendants
- 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
- K092624: Firebird Spinal Fixation System (2009), 130 descendants of its own
- K100044: Firebird Spinal Fixation System, Firebird Side-Loading Body (2010), 117 descendants of its own

## Indications for use
The 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 spondylolistheses 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 screw fixation to the non-cervical spine, is intended for the following indications: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies); b) spondylolistheses; c) spinal stenosis; d) spinal deformities (i.e., scoliosis, kyphosis, lordosis); e) tumor; f) pseudoarthrosis; g) previous failed fusion; and h) trauma (i.e., fracture or dislocation). The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies); b) spondylolistheses; c) spinal stenosis; d) spinal deformities (i.e., scoliosis, kyphosis, lordosis); e) tumor; f) pseudoarthrosis; g) previous failed fusion; and h) trauma (i.e., fracture or dislocation).

Source page: https://510kreport.com/device/K030581
Methodology: https://510kreport.com/methodology