# K172469: TiLock Modular Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Nov 30, 2017 after 107 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). 195 ancestors in all.
No later device cites it as a predicate yet.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161914: Genesys Spine TiLock Cortical Spinal System, Genesys Spine (2016) Summary page 4.
- K171838: TiLock2 Spinal System, Genesys Spine (2017) Summary page 4.
- K100757: Tilock Pedicle Screw System, Genesys Spine (2010) Summary page 4.
- K103671: Genesys Spine Tilock System, Genesys Spine (2011) Summary page 4.
- K142737: MAS PLIF Fixation system, Nu Vasive, Incorporated (2014) Summary page 4.

## Indications for use
The Genesys Spine TiLock Modular Spinal System is intended for the following indications: The Genesys Spine TiLock Modular Spinal System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, 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 posterior thoracic, lumbar, and sacral spine: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. When used for posterior non-cervical screw fixation in pediatric patients, Genesys Spine TiLock Modular Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Genesys Spine TiLock Modular Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. The Genesys Spine TiLock Modular Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Genesys Spine TiLock Modular Spinal System is also intended for the following indications: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion

Source page: https://510kreport.com/device/K172469
Methodology: https://510kreport.com/methodology