Atlas FDA

Identity Shoulder System

FDA 510(k) clearance K250848 · decided 2025-07-02

Clearance details

K-number
K250848
Device name
Identity Shoulder System
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2025-03-20
Decision date
2025-07-02
Days to decision
104 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.

RecordFirmDate
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (K253592)Zimmer, Inc.2026-04-13
Identity Revision Humeral Stems (K251098)Zimmer, Inc.2025-08-11
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 UC2023-11-13
INHANCE™ Shoulder System, Sterile Single Use Instrumentation (K231516)Depuy Ireland UC2023-07-21
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 UC2022-06-08
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

RecordFirmDate
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