# K093926: Firebird Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Jul 28, 2010 after 218 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). 88 ancestors in all.
88 later devices descend from it; 2 cite it directly.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092624: Firebird Spinal Fixation System, Blackstone Medical, Inc. (2009) Summary page 2.
- K082797: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008) Summary page 2.
- K081684: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008) 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.
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 2.
- K993030: Modification to Isola Spinal System, Depuyacromed (1999) Summary page 2.
- K024348: Monarch Spine System, Depuyacromed (2003) Summary page 2.

## Most influential descendants
- 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
- K180179: Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw (2018), 37 descendants of its own

## Indications for use
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). The system is limited to use in skeletally mature 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) tumor, 7) pseudoarthrosis, and 8) failed previous fusion When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level. The Firebird Spinal Fixation System components are used with certain components of the SFS system, including rod connectors and cross-connectors.

Source page: https://510kreport.com/device/K093926
Methodology: https://510kreport.com/methodology