FDA.reportPublic FDA data

510(k) K253592

Device
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
Applicant
Zimmer, Inc.
510(k) number
K253592
Product code
MBF
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-13
Date received
2025-11-17
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
N

Applicant Contact#

Contact
Alexandria Irwin
Address
1800 W. Center St. Warsaw IN US 46850 46850

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MBF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251098Identity Revision Humeral StemsZimmer, Inc.2025-08-11
K250848Identity Shoulder SystemZimmer, Inc.2025-07-02
K240876Identity Shoulder SystemZimmer, Inc.2024-06-12
K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.2024-01-11
K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.2023-12-21
K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC2023-11-13
K231516INHANCE™ Shoulder System, Sterile Single Use InstrumentationDepuy Ireland UC2023-07-21
K223876SMR Shoulder SystemLima Corporate S.P.A.2023-02-03
K222427PRIMA TT GlenoidLima Corporate S.P.A.2022-10-06
K213856Identity Shoulder SystemZimmer, Inc.2022-09-15
K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC2022-06-08
K220792SMR Reverse LinerLima Corporate S.P.A.2022-05-19
K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC2021-05-20
K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.2020-12-17
K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp2020-10-28