StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
FDA 510(k) K161273 · Biomet, Inc.
510(k) numberK161273
Submission
- Device name
- StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- May 5, 2016
- Decision date
- January 25, 2017
- 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
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|---|---|---|---|
| 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 |
| K190216 | SpaceFlex KneeMBB · Traditional | G21, S.R.L. | 06/09/2019SE |
More from G21, S.R.L.
| 510(k) | Device | Decision |
|---|---|---|
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | 07/01/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | 05/19/2026SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | 05/22/2024SE |
| K222760 | StageOne Select Hip Cement Spacer MoldsMBB · Traditional | 12/28/2022SE |
| K221968 | StageOne Shoulder Cement Spacer MoldsMBB · Traditional | 09/15/2022SE |
| K213287 | StageOne Knee Cement Spacer MoldsMBB · Traditional | 09/02/2022SE |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | 02/07/2022SE |
| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | 12/10/2021SE |
| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…MBI · Traditional | 11/10/2020SE |
Questions and answers
When was StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis cleared by the FDA?
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis (K161273) received a 510(k) decision of Substantially Equivalent on January 25, 2017, 265 days after the submission was received.
What is the product code of K161273?
The FDA product code is MBB – Bone Cement, Antibiotic, a Class II (moderate risk) device regulated under 21 CFR 888.3027.