# K080407: Blackstone SFS Parallel Rod Connectors

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Mar 13, 2008 after 28 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K980447 (1998). 14 ancestors in all.
296 later devices descend from it; 8 cite it directly.
0 of 311 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.
- 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.
- K030241: Modification to Blackstone Spinal Fixation System, Blackstone Medical, Inc. (2003) Summary page 1.
- K030862: Blackstone Spinal Fixation System Rigid Cross Connector, Blackstone Medical, Inc. (2003) Summary page 1.
- K030581: Blackstone Spinal Fixation System Lateral Offset (System Modification), Blackstone Medical, Inc. (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K011358: Blackstone SES 4.5mm Mono-Axial Screws. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- 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
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System (2012), 116 descendants of its own

## Recalls of this device
- Feb 1, 2013 · Class II · Z-0896-2013: There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthof

## 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 LS-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 impainnent; 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/K080407
Methodology: https://510kreport.com/methodology