# K141186: Firebird Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Jan 2, 2015 after 240 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: 14 generations back to K040583 (2004). 229 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130932: Firebird Spinal Fixation System, Orthofix, Inc. (2013) Summary page 4.
- K120760: LDR Spine Spinetune TL Spinal System, Ldr Spine USA, Inc. (2012) Summary page 4.

## Most influential descendants
- K201420: Republic Spine Dark Star Spinal System (2021), 2 descendants of its own
- K223096: Dark Star Deformity Pedicle Screw System (2023), 1 descendant of its own
- K231443: Mini-OSTEO Pedicle Fixation System (2023), 0 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). 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: a) Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); b) Spondylolisthesis; c) Trauma (i.e., fracture or dislocation); d) Spinal stenosis; e) Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); f) Tumors; g) Pseudoarthrosis, and h) 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 Phoenix MIS 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. The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K141186
Methodology: https://510kreport.com/methodology