FDA.reportPublic FDA data

510(k) K193038

Device
Comprehensive Shoulder System
Applicant
Biomet Manufacturing Corp.
510(k) number
K193038
Product code
MBF  
Decision
Substantially Equivalent (SESE)
Decision date
2020-10-28
Date received
2019-10-31
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
Patricia Sandborn Beres
Address
56 E. Bell Dr. Warsaw IN US 46580 46580

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
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

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases