# K092624: Firebird Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Sep 25, 2009 after 30 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 7 generations back to K980447 (1998). 58 ancestors in all.
130 later devices descend from it; 5 cite it directly.
0 of 189 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.
- K080792: K2M Cocr Rod, K2m, Inc. (2008) Summary page 2.
- K061162: Bar Pedicle Screw Spinal Fixation System, Model 2020, Applied Spine Technologies, Inc. (2006) Summary page 2.

## Most influential descendants
- 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
- K093926: Firebird Spinal Fixation System (2010), 88 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

## Recalls of this device
- Apr 1, 2011 · Not classified · Z-3162-2011: Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse.

## 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: 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 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/K092624
Methodology: https://510kreport.com/methodology