# 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

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Aug 24, 2018 after 213 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: 17 generations back to K040583 (2004). 239 ancestors in all.
37 later devices descend from it; 12 cite it directly.
0 of 277 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Orthofix, Inc. (2017) Summary page 5.
- K160879: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems, Medos International Sàrl (2016) Summary page 5.

## Most influential descendants
- K223273: ASTRA Spine System (2022), 8 descendants of its own
- K233508: iFuse Bedrock Granite® Implant System (2024), 5 descendants of its own
- K203163: ARx Illiac Spinal Screw System (2020), 5 descendants of its own
- K211113: Zavation Spinal System (2021), 4 descendants of its own
- K210539: CoreLink Midline Fixation System (2021), 4 descendants of its own

## Indications for use
The Firebird Spinal Fixation Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities: 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 Systems components are used with certain components of the Spinal Fixation System (SFS), including rods, rod connectors and cross-connectors. When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Firebird Spinal Fixation Systems are intended to be used with autograft or allograft. The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The JANUS Midline Fixation Screw and the JANUS Fenestrated Screw when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with an open, minimally invasive or midline approach for posterior spinal surgery. The JANUS Fenestrated Screws are intended to be used with saline and radiopaque dye.

Source page: https://510kreport.com/device/K180179
Methodology: https://510kreport.com/methodology