# K152039: Genesys Spine TiLock2 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Oct 28, 2015 after 98 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: 10 generations back to K990745 (1999). 66 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100757: Tilock Pedicle Screw System, Genesys Spine (2010) Summary page 4.
- K103671: Genesys Spine Tilock System, Genesys Spine (2011) Summary page 4.
- K984578: Synergy D2 Spinal Implants, Interpore Cross Intl. (1999) Summary page 4.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 4.

## Most influential descendants
- K171838: TiLock2 Spinal System (2017), 4 descendants of its own
- K201427: Trivergent Spinal Fixation System (2020), 2 descendants of its own
- K253169: Duet™ Spinal Fixation System (2026), 1 descendant of its own
- K161914: Genesys Spine TiLock Cortical Spinal System (2016), 1 descendant of its own
- K262712: Duet™ Spinal Fixation System (2026), 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 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K152039
Methodology: https://510kreport.com/methodology