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510(k) K252885

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System by Astura Medical — Product Code PML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2026
Date Received
September 10, 2025
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 Astura Medical

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  • K222097 — OLYMPIC Deformity Band System (May 4, 2023)
  • K222554 — EL CAPITAN Anterior Lumbar Interbody Fusion (January 19, 2023)
  • K214047 — EL CAPITAN Anterior Lumbar Interbody Fusion System (March 30, 2022)

Other clearances for product code PML

  • 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)
  • K222789 — VADER® Pedicle System, G21 Cement (January 9, 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)