# K102204: Choice Spine Starfire Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine, LP
- Decided: Nov 15, 2010 after 102 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: 9 generations back to K853033 (1985). 62 ancestors in all.
88 later devices descend from it; 2 cite it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K081684: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008) Summary page 1.
- K041592: Coral Spinal System, Theken Surgical (2004) Summary page 1.
- K062174: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 1.

## Most influential descendants
- K132049: Thunderbolt and Lancer  Pedicle Screw Systems (2014), 82 descendants of its own
- K160775: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (2016), 73 descendants of its own
- K181677: Kodiak Spinal Fixation System (2018), 70 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own
- K203056: Invictus™ Spinal Fixation System (2020), 61 descendants of its own

## Indications for use
The STARFIRETM Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (DOD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordlosis); tumor; pseudloarthrosis; and failed previous fusion

Source page: https://510kreport.com/device/K102204
Methodology: https://510kreport.com/methodology