# K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix
- Decided: Dec 3, 2012 after 73 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: 9 generations back to K980447 (1998). 66 ancestors in all.
116 later devices descend from it; 6 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)
- K082797: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008) Summary page 2.
- K092624: Firebird Spinal Fixation System, Blackstone Medical, Inc. (2009) Summary page 2.
- K100044: Firebird Spinal Fixation System, Firebird Side-Loading Body, Blackstone (2010) Summary page 2.

## Cited in the summary but kept off the family tree
- K081684: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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 fixation. Pedicle screw fixation is limited to 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: *degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) *spondylolisthesis, *trauma (i.e., fracture or dislocation), *spinal stenosis, *deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), *tumor, *pseudoarthrosis, and *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. The Phoenix MIS Spinal Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Source page: https://510kreport.com/device/K122901
Methodology: https://510kreport.com/methodology