# 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

- Pathway: 510(k) (Special)
- Applicant: Orthofix, Inc.
- Decided: May 5, 2017 after 24 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: 16 generations back to K040583 (2004). 227 ancestors in all.
61 later devices descend from it; 6 cite it directly.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153428: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, Orthofix, Inc. (2016) Summary page 5.
- K080407: Blackstone SFS Parallel Rod Connectors, Blackstone Medical, Inc. (2008) Summary page 5.

## Most influential descendants
- 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
- K173130: Reform® Midline Cortical Screw System (2017), 21 descendants of its own
- K223273: ASTRA Spine System (2022), 8 descendants of its own
- K220862: E-GPS Navigated Instruments (2022), 7 descendants of its own
- K193396: PERLA® TL posterior osteosynthesis system (2020), 7 descendants of its own

## Recalls of this device
- Aug 2, 2017 · Class II · Z-3127-2017: The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.

## Indications for use
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System 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 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 and Phoenix MIS 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 pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System 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 System and Phoenix MIS Spinal Fixation System are intended to be used with autograft or allograft.

Source page: https://510kreport.com/device/K171082
Methodology: https://510kreport.com/methodology