510(k) K240876
- Device
- Identity Shoulder System
- Applicant
- Zimmer, Inc.
- 510(k) number
- K240876
- Product code
- MBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-12
- Date received
- 2024-03-29
- Regulation
- 888.3670
- Classification name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Patricia Beres
- Address
- 1800 W. Center St. Warsaw IN US 46580 46580
FDA Registration Numbers
- 3020967480
- 3006128100
- 2029275
- 8010379
- 2528981
- 3003898228
- 1835444
- 1423662
- 3021008900
- 3007740680
- 1836116
- 3016851379
- 3012544635
- 1422572
- 3008110533
- 3007993775
- 3026771806
- 3010331645
- 3008868758
- 3014315560
- 1644408
- 1064858
- 9616671
- 8043792
- 3014680795
- 1818910
- 3009475821
- 3015231789
- 3008812560
- 3008021110
- 9616944
- 3005180920
- 3009417901
- 1020279
- 3011015572
- 1825034
- 2183946
- 3002806470
- 1221934
- 3013055499
- 1828288
- 1822565
- 3013791180
- 1526534
- 1220246
- 3003403260
- 3009546990
- 3012319330
- 3015207155
- 3010173425
- 3011274144
- 1835831
- 3004748528
- 1834379
- 3006801265
- 3002579136
- 1834331
- 3006946276
- 9617840
- 3010163695
- 3008534770
- 3008744062
- 1000200989
- 1424263
- 3010386387
- 3008791302
- 3008395353
- 3013176080
- 3011461101
- 3007923096
- 3035366890
- 3004976965
- 3027484613
- 3014302784
- 3004153896
- 1529009
- 3038503932
- 3010178296
- 3010057495
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00887868580765 | Identity® Shoulder System | Zimmer, Inc. | 2024-09-09 |
| 00887868580758 | Identity® Shoulder System | Zimmer, Inc. | 2024-09-09 |
| 00887868580727 | Identity® Shoulder System | Zimmer, Inc. | 2024-09-09 |
| 00887868580710 | Identity® Shoulder System | Zimmer, Inc. | 2024-09-09 |
| 00887868580703 | Identity® Shoulder System | Zimmer, Inc. | 2024-09-09 |
| 00887868580697 | Identity® Shoulder System | Zimmer, Inc. | 2024-09-09 |
| 00887868580680 | Identity® Shoulder System | Zimmer, Inc. | 2024-09-09 |
Other 510(k) Records For Product Code MBF
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Zimmer, Inc. | 2026-04-13 |
| K251098 | Identity Revision Humeral Stems | Zimmer, Inc. | 2025-08-11 |
| K250848 | Identity Shoulder System | Zimmer, Inc. | 2025-07-02 |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024-01-11 |
| K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023-12-21 |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | 2023-11-13 |
| K231516 | INHANCE Shoulder System, Sterile Single Use Instrumentation | Depuy Ireland UC | 2023-07-21 |
| K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023-02-03 |
| K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022-10-06 |
| K213856 | Identity Shoulder System | Zimmer, Inc. | 2022-09-15 |
| K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | Depuy Ireland UC | 2022-06-08 |
| K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022-05-19 |
| K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021-05-20 |
| K201905 | SMR 140° Reverse Humeral Body | Lima Corporate S.P.A. | 2020-12-17 |
| K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020-10-28 |