FDA.report

510(k) K233712

Device
PRIMA Humeral System; PRIMA TT Glenoid
Applicant
Lima Corporate S.P.A.
510(k) number
K233712
Product code
MBF
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-11
Date received
2023-11-20
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
Michela Zanotto
Address
Via Nazionale, 52 Villanova Di San Daniele IT 33038 33038

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MBF

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
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