SpaceFlex Knee
FDA 510(k) K190216 · G21, S.R.L.
510(k) numberK190216
Submission
- Device name
- SpaceFlex Knee
- Applicant
- G21, S.R.L.
San Possidomio, IT - Received
- February 4, 2019
- Decision date
- June 9, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBB – Bone Cement, Antibiotic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252443 | SpaceFix Shoulder SpacerMBB · Traditional | G21, S.R.L. | 09/15/2025SE |
| K242216 | Gentafix® (1, 3, 3MV)MBB · Traditional | Teknimed Sas | 12/18/2024SE |
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsMBB · Traditional | Osartis GmbH | 11/20/2024SE |
| K222760 | StageOne Select Hip Cement Spacer MoldsMBB · Traditional | Biomet, Inc. | 12/28/2022SE |
| K221968 | StageOne Shoulder Cement Spacer MoldsMBB · Traditional | Biomet, Inc. | 09/15/2022SE |
| K213287 | StageOne Knee Cement Spacer MoldsMBB · Traditional | Biomet, Inc. | 09/02/2022SE |
| K202338 | SpaceFlex ShoulderMBB · Traditional | G21, S.R.L. | 02/17/2021SE |
| K201960 | SpaceFlex Knee - 80mm SizeMBB · Special | G21, S.R.L. | 08/13/2020SE |
| K192041 | G21 SpaceFlex HipMBB · Traditional | G21, S.R.L. | 10/29/2019SE |
| K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisMBB · Traditional | Biomet, Inc. | 01/25/2017SE |
More from Biomet, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252443 | SpaceFix Shoulder SpacerMBB · Traditional | 09/15/2025SE |
| K223441 | SpaceFlex Acetabular CupKWY · Traditional | 03/23/2023SE |
| K202338 | SpaceFlex ShoulderMBB · Traditional | 02/17/2021SE |
| K201960 | SpaceFlex Knee - 80mm SizeMBB · Special | 08/13/2020SE |
| K193061 | G3 40 Radiopaque Bone CementLOD · Traditional | 03/19/2020SE |
| K193059 | G1 40 Radiopaque Bone CementLOD · Traditional | 03/19/2020SE |
| K192041 | G21 SpaceFlex HipMBB · Traditional | 10/29/2019SE |
| K181282 | G3A 40 Bone CementLOD · Traditional | 01/09/2019SE |
| K173494 | OrthoSteady G Bone CementLOD · Traditional | 03/06/2018SE |
| K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersNDN · Traditional | 02/23/2016SE |
Questions and answers
When was SpaceFlex Knee cleared by the FDA?
SpaceFlex Knee (K190216) received a 510(k) decision of Substantially Equivalent on June 9, 2019, 125 days after the submission was received.
What is the product code of K190216?
The FDA product code is MBB – Bone Cement, Antibiotic, a Class II (moderate risk) device regulated under 21 CFR 888.3027.