SMR Hybrid Glenoid System
FDA 510(k) K163397 · Lima Corporate S.P.A.
510(k) numberK163397
Submission
- Device name
- SMR Hybrid Glenoid System
- Applicant
- Lima Corporate S.P.A.
Villanova Di San Daniele Udine, IT - Received
- December 5, 2016
- Decision date
- June 29, 2017
- 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 |
|---|---|---|
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemPHX · Traditional | 01/22/2026SE |
| K251718 | ArTT Augments and Buttresses and Bone ScrewsLPH · Traditional | 08/29/2025SE |
| K243826 | SMR Reverse HP Shoulder SystemPHX · Traditional | 07/03/2025SE |
| K250980 | Physica System (Physica CR Porous Femoral components)MBH · Traditional | 05/22/2025SE |
| K243615 | Physica Porous Femoral ComponentsMBH · Special | 12/18/2024SE |
| K234011 | AMF TT ConesJWH · Special | 01/18/2024SE |
| K233712 | PRIMA Humeral System; PRIMA TT GlenoidMBF · Traditional | 01/11/2024SE |
| K231099 | SMR Hybrid Glenoid SystemMBF · Traditional | 12/21/2023SE |
| K231925 | MINIMA S SystemLZO · Special | 07/11/2023SE |
| K221758 | SMR Stemless AnatomicPKC · Traditional | 03/17/2023SE |
Questions and answers
When was SMR Hybrid Glenoid System cleared by the FDA?
SMR Hybrid Glenoid System (K163397) received a 510(k) decision of Substantially Equivalent on June 29, 2017, 206 days after the submission was received.
What is the product code of K163397?
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.