# K100757: Tilock Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Jul 1, 2010 after 106 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K955348 (1996). 28 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984578: Synergy D2 Spinal Implants, Interpore Cross Intl. (1999) Summary page 2.
- K081252: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 2.
- K041801: Expedium Mis Spine System, Depuy Spine, Inc. (2004) Summary page 2.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 2.
- K984350: VSP System, Depuy Motech Acromed (1999) Summary page 2.
- K983904: Rogozinski Spinal Rod System, United States Surgical, A Division of Tyco Healthc (1998) Summary page 2.

## Most influential descendants
- K103671: Genesys Spine Tilock System (2011), 8 descendants of its own
- K152039: Genesys Spine TiLock2 Spinal System (2015), 7 descendants of its own
- 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

## Recalls of this device
- Apr 2, 2014 · Class II · Z-2677-2014: The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured u

## Indications for use
The TiLock 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 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, kyph~osis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K100757
Methodology: https://510kreport.com/methodology