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510(k) K222789

VADER® Pedicle System, G21 Cement by Icotec AG — Product Code PML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2023
Date Received
September 15, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement, Posterior Screw Augmentation
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

The device is intended to augment the fixation of screws in a posterior spinal system construct.

Other clearances by Icotec AG

  • K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments (November 12, 2025)
  • K242900 — VADER® Pedicle System and VADER®one Pedicle System (February 27, 2025)
  • K233215 — icotec Anterior Cervical Plate System (May 17, 2024)
  • K232792 — icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, ico (April 5, 2024)
  • K232790 — KONG®-TL VBR System and KONG® C VBR System (April 4, 2024)
  • K232628 — VADER® Pedicle System (February 26, 2024)
  • K230861 — VADER® Pedicle System Navigated Instruments (June 27, 2023)
  • K201587 — icotec Anterior Cervical Plate System (October 15, 2020)
  • K200596 — G21 Cement, VADER® Pedicle System (October 13, 2020)
  • K200235 — KONG-TL VBR System, KONG-C VBR System (May 29, 2020)

Other clearances for product code PML

  • K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (January 22, 2026)
  • K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System (June 12, 2024)
  • K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Moment (October 20, 2023)
  • K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement (June 23, 2023)
  • K221926 — Invictus® Bone Cement, Invictus Spinal Fixation System (December 20, 2022)
  • K222256 — BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (August 26, 2022)
  • K212489 — BonOs Inject Bone Cement; NEO Pedicle Screw System (October 28, 2021)
  • K200596 — G21 Cement, VADER® Pedicle System (October 13, 2020)
  • K201362 — CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone (August 19, 2020)
  • K192818 — Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal Syste (March 31, 2020)