# K130932: Firebird Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Aug 7, 2013 after 125 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: 13 generations back to K040583 (2004). 224 ancestors in all.
81 later devices descend from it; 4 cite it directly.
0 of 306 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 3.
- K082797: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008) Summary page 3.
- K100044: Firebird Spinal Fixation System, Firebird Side-Loading Body, Blackstone (2010) Summary page 3.
- K093926: Firebird Spinal Fixation System, Blackstone Medical, Inc. (2010) Summary page 3.
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System, Orthofix (2012)
- K113666: Xia 3 Spinal System, Stryker Spine (2012)
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 3.
- K994121: Small Stature Uss, Synthes (Usa) (2000) Summary page 3.
- K121630: Range Spinal System, K2m, Inc. (2012) Summary page 3.
- K111492: Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments, Materialise NV (2011)

## Most influential descendants
- 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
- K173130: Reform® Midline Cortical Screw System (2017), 21 descendants of its own

## Recalls of this device
- May 18, 2015 · Class II · Z-1749-2015: The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.

## Indications for use
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non-pedicle fixation (TI-52/Iliumn). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allagraft. 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) * spondy lolisthesis, * trauma (i.e., fracture or dislocation), * spinal stenosis, * deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), * tumnor, * pseudoarthrosis, and * failed previous fusion When used far fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the SI 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/K130932
Methodology: https://510kreport.com/methodology