SpaceFlex Knee— 510(k) K190216

Name: FDA 510(k) clearance K190216
Creator: U.S. Food and Drug Administration
Published: 2019-06-09

Substantially Equivalent

G21, S.R.L.

FDA 510(k) clearance K190216 for SpaceFlex Knee, Substantially Equivalent on 2019-06-09. Applicant: G21, S.R.L.. Device class: 2.

Clearance details

Applicant: G21, S.R.L.
Product code: Code MBB
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2019-02-04
Decision date: 2019-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Possidomio, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBB

view all

K252443 — SpaceFix Shoulder Spacer2025-09-15
K242216 — GENTAFIX® (1, 3, 3MV)2024-12-18
K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds2024-11-20
K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

More clearances from G21, S.R.L.

view all

K223441 — SpaceFlex Acetabular Cup2023-03-23
K202338 — SpaceFlex Shoulder2021-02-17
K201960 — SpaceFlex Knee - 80mm Size2020-08-13
K193059 — G1 40 Radiopaque Bone Cement2020-03-19
K193061 — G3 40 Radiopaque Bone Cement2020-03-19

Adverse events under product code MBB

product code MBB

Death: 27
Injury: 1,412
Malfunction: 551
Total: 1,990

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.