Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds
FDA 510(k) K240856 · Osartis GmbH
510(k) numberK240856
Submission
- Device name
- Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds
- Applicant
- Osartis GmbH
Münster, DE - Received
- March 28, 2024
- Decision date
- November 20, 2024
- 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 |
| 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 |
| K190216 | SpaceFlex KneeMBB · Traditional | G21, S.R.L. | 06/09/2019SE |
| K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisMBB · Traditional | Biomet, Inc. | 01/25/2017SE |
More from Biomet, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusherLOD · Traditional | 05/18/2021SE |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV GentaLOD · Traditional | 03/19/2021SE |
| K210120 | BonOs HV, BonOs MV, BonOs LVLOD · Traditional | 03/19/2021SE |
| K192394 | Hi-Fatigue Bone CementLOD · Traditional | 12/02/2019SE |
| K192379 | Hi-Fatigue G Bone CementLOD · Traditional | 11/27/2019SE |
Questions and answers
When was Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds cleared by the FDA?
Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (K240856) received a 510(k) decision of Substantially Equivalent on November 20, 2024, 237 days after the submission was received.
What is the product code of K240856?
The FDA product code is MBB – Bone Cement, Antibiotic, a Class II (moderate risk) device regulated under 21 CFR 888.3027.