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510(k) K242216

GENTAFIX® (1, 3, 3MV) by Teknimed Sas — Product Code MBB

K242216 is an FDA 510(k) premarket notification submitted by Teknimed Sas for the device "GENTAFIX® (1, 3, 3MV)". The FDA issued a decision of Substantially Equivalent on December 18, 2024. The device falls under product code MBB (Bone Cement, Antibiotic), a Class II device regulated under 21 CFR 888.3027. Teknimed Sas has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2024
Date Received
July 29, 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 Teknimed Sas

  • K230394 — EUROSCREW NG; EUROSCREW TCP NG (May 12, 2023)
  • K161114 — HIGH V+ (April 12, 2017)
  • K103816 — COHESION BONE CEMENT (February 4, 2011)
  • K103433 — F20 (January 3, 2011)
  • K090435 — VERTECEM (December 21, 2009)
  • K083005 — NANGEL (March 4, 2009)
  • K080873 — OPACITY + BONE CEMENT (August 28, 2008)
  • K062102 — ODONCER (April 16, 2007)
  • K043593 — SPINE-FIX BIOMIMETIC BONE CEMENT (March 17, 2006)
  • K042911 — CEMENTEK LV (December 27, 2004)

Other clearances for product code MBB

  • K252443 — SpaceFix Shoulder Spacer (September 15, 2025)
  • K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (November 20, 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)

FDA data resources