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510(k) K240856

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds by Osartis GmbH — Product Code MBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2024
Date Received
March 28, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement, Antibiotic
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

Other clearances by Osartis GmbH

  • K202458 — BonOs Inject, Pedicle screw kits, Cement pusher (May 18, 2021)
  • K210120 — BonOs HV, BonOs MV, BonOs LV (March 19, 2021)
  • K210125 — BonOs HV Genta, BonOs MV Genta, BonOs LV Genta (March 19, 2021)
  • K192394 — Hi-Fatigue Bone Cement (December 2, 2019)
  • K192379 — Hi-Fatigue G Bone Cement (November 27, 2019)

Other clearances for product code MBB

  • K252443 — SpaceFix Shoulder Spacer (September 15, 2025)
  • K242216 — GENTAFIX® (1, 3, 3MV) (December 18, 2024)
  • K222760 — StageOne™ Select Hip Cement Spacer Molds (December 28, 2022)
  • K221968 — StageOne™ Shoulder Cement Spacer Molds (September 15, 2022)
  • K213287 — StageOne Knee Cement Spacer Molds (September 2, 2022)
  • K202338 — SpaceFlex Shoulder (February 17, 2021)
  • K201960 — SpaceFlex Knee - 80mm Size (August 13, 2020)
  • K192041 — G21 SpaceFlex Hip (October 29, 2019)
  • K190216 — SpaceFlex Knee (June 9, 2019)
  • K161273 — StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis (January 25, 2017)