Compress Segmental Humeral Replacement System
FDA 510(k) K123297 · Biomet Manufactuting Corp.
510(k) numberK123297
Submission
- Device name
- Compress Segmental Humeral Replacement System
- Applicant
- Biomet Manufactuting Corp.
Warsaw, IN, US - Received
- October 22, 2012
- Decision date
- November 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K142746 | G7 Finned Acetabular ShellLPH · Traditional | 12/29/2014SE |
Questions and answers
When was Compress Segmental Humeral Replacement System cleared by the FDA?
Compress Segmental Humeral Replacement System (K123297) received a 510(k) decision of Substantially Equivalent on November 20, 2012, 29 days after the submission was received.
What is the product code of K123297?
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.