Compress and Mini Compress Anti-Rotation Spindles
FDA 510(k) K183553 · Biomet, Inc.
510(k) numberK183553
Submission
- Device name
- Compress and Mini Compress Anti-Rotation Spindles
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- December 20, 2018
- Decision date
- January 22, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3670
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…MBF · Traditional | Zimmer, Inc. | 04/13/2026SE |
| K251098 | Identity Revision Humeral StemsMBF · Traditional | Zimmer, Inc. | 08/11/2025SE |
| K250848 | Identity Shoulder SystemMBF · Traditional | Zimmer, Inc. | 07/02/2025SE |
| K240876 | Identity Shoulder SystemMBF · Traditional | Zimmer, Inc. | 06/12/2024SE |
| K233712 | PRIMA Humeral System; PRIMA TT GlenoidMBF · Traditional | Lima Corporate S.P.A. | 01/11/2024SE |
| K231099 | SMR Hybrid Glenoid SystemMBF · Traditional | Lima Corporate S.P.A. | 12/21/2023SE |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidMBF · Traditional | Depuy Ireland UC | 11/13/2023SE |
| K231516 | INHANCE Shoulder System, Sterile Single Use InstrumentationMBF · Traditional | Depuy Ireland UC | 07/21/2023SE |
| K223876 | SMR Shoulder SystemMBF · Traditional | Lima Corporate S.P.A. | 02/03/2023SE |
| K222427 | PRIMA TT GlenoidMBF · Traditional | Lima Corporate S.P.A. | 10/06/2022SE |
More from Lima Corporate S.P.A.
| 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 Compress and Mini Compress Anti-Rotation Spindles cleared by the FDA?
Compress and Mini Compress Anti-Rotation Spindles (K183553) received a 510(k) decision of Substantially Equivalent on January 22, 2019, 33 days after the submission was received.
What is the product code of K183553?
The FDA product code is MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3670.