TILOCK PEDICLE SCREW SYSTEM— 510(k) K100757

Clearance details

Applicant

Genesys Spine

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2010-03-17

Decision date

2010-07-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Austin, TX, US

• K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-09-04
• K253943 — Tiger 2 System2026-07-24
• K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)2026-07-24
• K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System2026-07-14
• K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-07-01

• K252322 — SIros-X System2025-10-22
• K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System2025-02-07
• K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation2024-03-29
• K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System2023-12-13
• K220096 — Genesys Spine 3DP Lumbar Interbody System2022-03-09

Death

27

Injury

5,033

Malfunction

4,140

Total

9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2677-2014 — Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).Class II·Terminated·Genesys Orthopedics Systems, LLC·20140402

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100757.