Home / 510(k) Clearances / K172469

510(k) K172469

TiLock Modular Spinal System by Genesys Spine — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2017
Date Received
August 15, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Genesys Spine

  • K252322 — SIros-X System (October 22, 2025)
  • K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System (February 7, 2025)
  • K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation (March 29, 2024)
  • K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System (December 13, 2023)
  • K220096 — Genesys Spine 3DP Lumbar Interbody System (March 9, 2022)
  • K191489 — Genesys Spine 3DP Cervical Interbody System (January 8, 2020)
  • K182987 — Genesys Spine 3DP Lumbar Interbody System (December 12, 2019)
  • K192678 — Genesys Spine Binary® Lumbar Plate System (October 24, 2019)
  • K191748 — Genesys Spine Sacroiliac Joint Fusion System (September 26, 2019)
  • K192076 — Binary® Anterior Cervical Plate System (August 29, 2019)

Other clearances for product code NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)