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510(k) K161914

Genesys Spine TiLock Cortical Spinal System by Genesys Spine — Product Code NKB

K161914 is an FDA 510(k) premarket notification submitted by Genesys Spine for the device "Genesys Spine TiLock Cortical Spinal System". The FDA issued a decision of Substantially Equivalent on August 9, 2016. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Genesys Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2016
Date Received
July 12, 2016
Clearance Type
Special
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

  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)

FDA data resources