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510(k) K201960

SpaceFlex Knee - 80mm Size by G21, S.R.L. — Product Code MBB

K201960 is an FDA 510(k) premarket notification submitted by G21, S.R.L. for the device "SpaceFlex Knee - 80mm Size". The FDA issued a decision of Substantially Equivalent on August 13, 2020. The device falls under product code MBB (Bone Cement, Antibiotic), a Class II device regulated under 21 CFR 888.3027. G21, S.R.L. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2020
Date Received
July 14, 2020
Clearance Type
Special
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 G21, S.R.L.

  • K252443 — SpaceFix Shoulder Spacer (September 15, 2025)
  • K223441 — SpaceFlex Acetabular Cup (March 23, 2023)
  • K202338 — SpaceFlex Shoulder (February 17, 2021)
  • K193061 — G3 40 Radiopaque Bone Cement (March 19, 2020)
  • K193059 — G1 40 Radiopaque Bone Cement (March 19, 2020)
  • K192041 — G21 SpaceFlex Hip (October 29, 2019)
  • K190216 — SpaceFlex Knee (June 9, 2019)
  • K181282 — G3A 40 Bone Cement (January 9, 2019)
  • K173494 — OrthoSteady G Bone Cement (March 6, 2018)
  • K152557 — Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters (February 23, 2016)

Other clearances for product code MBB

  • K252443 — SpaceFix Shoulder Spacer (September 15, 2025)
  • K242216 — GENTAFIX® (1, 3, 3MV) (December 18, 2024)
  • 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)
  • 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