PRIMA Humeral System and SMR Glenosphere Ø42
FDA 510(k) K212800 · Lima Corporate S.P.A.
510(k) numberK212800
Submission
- Device name
- PRIMA Humeral System and SMR Glenosphere Ø42
- Applicant
- Lima Corporate S.P.A.
Villanova Di San Daniele Del Friuli, IT - Received
- September 2, 2021
- Decision date
- February 25, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
Other 510(k)s with product code PHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260556 | Veritas Shoulder SystemPHX · Traditional | Restor3D | 07/01/2026SE |
| K261683 | Augment Off-Axis Instrument SystemPHX · Special | Zimmer, Inc. | 06/16/2026SE |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…PHX · Traditional | Stryker Corporation (Tornier, Inc.) | 06/12/2026SE |
| K261016 | MSS - Humeral reverse liners extensionPHX · Traditional | Medacta International, SA | 06/10/2026SE |
| K253992 | Veritas Reverse Total Shoulder SystemPHX · Traditional | Restor3D | 05/07/2026SE |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional | Biomet Orthopedics | 04/15/2026SE |
| K260583 | Equinoxe® Shoulder SystemPHX · Traditional | Exactech, Inc. | 04/14/2026SE |
| K254128 | InSet Reverse Total Shoulder SystemPHX · Traditional | Shoulder Innovations, Inc. | 04/13/2026SE |
| K253674 | Blueprint Patient-Specific InstrumentationPHX · Traditional | Stryker Corporation (Tornier, S.A.S.) | 04/03/2026SE |
| K253624 | INHANCE Reverse Shoulder SystemPHX · Traditional | Depuy Ireland UC | 03/11/2026SE |
More from Depuy Ireland UC
| 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 PRIMA Humeral System and SMR Glenosphere Ø42 cleared by the FDA?
PRIMA Humeral System and SMR Glenosphere Ø42 (K212800) received a 510(k) decision of Substantially Equivalent on February 25, 2022, 176 days after the submission was received.
What is the product code of K212800?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.