Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
FDA 510(k) clearance K253592 · decided 2026-04-13
Clearance details
- K-number
- K253592
- Device name
- Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-17
- Decision date
- 2026-04-13
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- MBF
- Device class
- 2
- Regulation number
- 888.3670
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Identity Revision Humeral Stems (K251098) | Zimmer, Inc. | 2025-08-11 |
| Identity Shoulder System (K250848) | Zimmer, Inc. | 2025-07-02 |
| Identity Shoulder System (K240876) | Zimmer, Inc. | 2024-06-12 |
| PRIMA Humeral System; PRIMA TT Glenoid (K233712) | Lima Corporate S.P.A. | 2024-01-11 |
| SMR Hybrid Glenoid System (K231099) | Lima Corporate S.P.A. | 2023-12-21 |
| INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (K230831) | Depuy Ireland UC | 2023-11-13 |
| INHANCE™ Shoulder System, Sterile Single Use Instrumentation (K231516) | Depuy Ireland UC | 2023-07-21 |
| SMR Shoulder System (K223876) | Lima Corporate S.P.A. | 2023-02-03 |
| PRIMA TT Glenoid (K222427) | Lima Corporate S.P.A. | 2022-10-06 |
| Identity Shoulder System (K213856) | Zimmer, Inc. | 2022-09-15 |
| INHANCETM Hybrid Anatomic Glenoid Implant (K212933) | Depuy Ireland UC | 2022-06-08 |
| SMR Reverse Liner (K220792) | Lima Corporate S.P.A. | 2022-05-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |