# K100044: Firebird Spinal Fixation System, Firebird Side-Loading Body

- Pathway: 510(k) (Special)
- Applicant: Blackstone
- Decided: Feb 4, 2010 after 27 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 8 generations back to K980447 (1998). 65 ancestors in all.
117 later devices descend from it; 2 cite it directly.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081684: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008) Summary page 2.
- K082797: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008) Summary page 2.
- K092624: Firebird Spinal Fixation System, Blackstone Medical, Inc. (2009) Summary page 2.
- K080407: Blackstone SFS Parallel Rod Connectors, Blackstone Medical, Inc. (2008) Summary page 2.
- K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 2.

## Most influential descendants
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System (2012), 116 descendants of its own
- K130932: Firebird Spinal Fixation System (2013), 81 descendants of its own
- K151488: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (2015), 78 descendants of its own
- K153428: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System (2016), 73 descendants of its own
- K171082: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System (2017), 61 descendants of its own

## Indications for use
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally m~ature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications: 1)degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) 2) spondylolisthesis, 3) trauma (i.e., fracture or dislocation), 4) spinal stenosis, 5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6) tumnor, 7) pseudoarthrosis, and 8) failed previous fusion The Firebird Spinal Fixation System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

Source page: https://510kreport.com/device/K100044
Methodology: https://510kreport.com/methodology