# K171456: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine
- Decided: Aug 3, 2017 after 78 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: 15 generations back to K040583 (2004). 278 ancestors in all.
No later device cites it as a predicate yet.
0 of 279 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132049: Thunderbolt and Lancer  Pedicle Screw Systems, Choicespine (2014) Summary page 5.
- K160775: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems, Choicespine, LP (2016) Summary page 5.
- K151488: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, Orthofix, Inc. (2015) Summary page 5.

## Indications for use
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are 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 (DDD; 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 lordosis); tumor; pseudoarthrosis; and failed previous fusion. When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior, non-cervical pedicle, and non-pedicle fixation The Lancer™ Open Pedicle Screw System is indicated for the following: degenerative disc disease (DDD) (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Overall levels of fixation are T1 to the Sacrum/Ilium. When used for fixation to the ilium, the lateral offset connectors of the Lancer™ Open Pedicle Screw System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

Source page: https://510kreport.com/device/K171456
Methodology: https://510kreport.com/methodology