# K171838: TiLock2 Spinal System

- Pathway: 510(k) (Special)
- Applicant: Genesys Spine
- Decided: Jul 19, 2017 after 29 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: 11 generations back to K990745 (1999). 113 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152039: Genesys Spine TiLock2 Spinal System, Genesys Spine (2015) 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.
- K122145: Lanx Spinal Fixation System, Lanx, Inc. (2012) Summary page 4.

## Most influential descendants
- K201427: Trivergent Spinal Fixation System (2020), 2 descendants of its own
- K253169: Duet™ Spinal Fixation System (2026), 1 descendant of its own
- K262712: Duet™ Spinal Fixation System (2026), 0 descendants of its own
- K172469: TiLock Modular Spinal System (2017), 0 descendants of its own

## Indications for use
The TiLock2 Spinal 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; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K171838
Methodology: https://510kreport.com/methodology