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510(k) K192041

G21 SpaceFlex Hip by G21, S.R.L. — Product Code MBB

K192041 is an FDA 510(k) premarket notification submitted by G21, S.R.L. for the device "G21 SpaceFlex Hip". The FDA issued a decision of Substantially Equivalent on October 29, 2019. 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
October 29, 2019
Date Received
July 31, 2019
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 G21, S.R.L.

  • K252443 — SpaceFix Shoulder Spacer (September 15, 2025)
  • K223441 — SpaceFlex Acetabular Cup (March 23, 2023)
  • K202338 — SpaceFlex Shoulder (February 17, 2021)
  • K201960 — SpaceFlex Knee - 80mm Size (August 13, 2020)
  • K193061 — G3 40 Radiopaque Bone Cement (March 19, 2020)
  • K193059 — G1 40 Radiopaque Bone Cement (March 19, 2020)
  • 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)
  • K201960 — SpaceFlex Knee - 80mm Size (August 13, 2020)
  • K190216 — SpaceFlex Knee (June 9, 2019)
  • K161273 — StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis (January 25, 2017)

FDA data resources