FDA.reportPublic FDA data

510(k) K231516

Device
INHANCE? Shoulder System, Sterile Single Use Instrumentation
Applicant
Depuy Ireland UC
510(k) number
K231516
Product code
MBF
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-21
Date received
2023-05-25
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

Applicant Contact#

Contact
Yayoi Fujimaki
Address
Loughbeg Ringaskiddy IE

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
K253592Zimmer 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
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
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