Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

FDA product code MBF · 36 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3670
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1985-01-23 – 2026-04-13

MBF 2026-04-13

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

Applicant Zimmer, Inc.

K number K253592

View details →

MBF 2025-08-11

Identity Revision Humeral Stems

Applicant Zimmer, Inc.

K number K251098

View details →

MBF 2025-07-02

Identity Shoulder System

Applicant Zimmer, Inc.

K number K250848

View details →

MBF 2024-06-12

Identity Shoulder System

Applicant Zimmer, Inc.

K number K240876

View details →

MBF 2024-01-11

PRIMA Humeral System; PRIMA TT Glenoid

Applicant Lima Corporate S.P.A.

K number K233712

View details →

MBF 2023-12-21

SMR Hybrid Glenoid System

Applicant Lima Corporate S.P.A.

K number K231099

View details →

MBF 2023-11-13

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid

Applicant Depuy Ireland UC

K number K230831

View details →

MBF 2023-07-21

INHANCE™ Shoulder System, Sterile Single Use Instrumentation

Applicant Depuy Ireland UC

K number K231516

View details →

MBF 2023-02-03

SMR Shoulder System

Applicant Lima Corporate S.P.A.

K number K223876

View details →

MBF 2022-10-06

PRIMA TT Glenoid

Applicant Lima Corporate S.P.A.

K number K222427

View details →

MBF 2022-09-15

Identity Shoulder System

Applicant Zimmer, Inc.

K number K213856

View details →

MBF 2022-06-08

INHANCETM Hybrid Anatomic Glenoid Implant

Applicant Depuy Ireland UC

K number K212933

View details →

MBF 2022-05-19

SMR Reverse Liner

Applicant Lima Corporate S.P.A.

K number K220792

View details →

MBF 2021-05-20

Ignite Anatomic Shoulder System

Applicant Ignite Orthopedics, LLC

K number K202716

View details →

MBF 2020-12-17

SMR 140° Reverse Humeral Body

Applicant Lima Corporate S.P.A.

K number K201905

View details →

MBF 2020-10-28

Comprehensive Shoulder System

Applicant Biomet Manufacturing Corp

K number K193038

View details →

MBF 2019-10-10

SMR Finned Short Stems

Applicant Lima Corporate S.P.A.

K number K191963

View details →

MBF 2019-01-22

Compress and Mini Compress Anti-Rotation Spindles

Applicant Biomet, Inc.

K number K183553

View details →

MBF 2018-10-23

Humeral Short Stem System

Applicant Shoulder Innovations, Inc.

K number K173824

View details →

MBF 2017-06-29

SMR Hybrid Glenoid System

Applicant Lima Corporate S.P.A.

K number K163397

View details →

MBF 2017-04-10

ARROW Anatomical Porous glenoid

Applicant Fournitures Hospitalieres Industrie

K number K162068

View details →

MBF 2013-08-06

SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM

Applicant Biomet, Inc.

K number K130126

View details →

MBF 2012-11-20

COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM

Applicant Biomet Manufactuting Corp.

K number K123297

View details →

MBF 2012-05-24

COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM

Applicant Biomet Orthopedics, LLC

K number K112905

View details →

MBF 2009-02-05

SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM

Applicant Synthes (Usa)

K number K083439

View details →

MBF 2008-09-30

ENCORE SHOULDER REVISION GLENOID

Applicant Encore Medical L.P.

K number K081448

View details →

MBF 2007-05-18

COFIELD TOTAL SHOULDER SYSTEM

Applicant Smith & Nephew, Inc.

K number K070565

View details →

MBF 2007-02-01

GLOBAL AP POROUS COATED HUMERAL STEM

Applicant DePuy Orthopaedics, Inc.

K number K063652

View details →

MBF 2006-06-12

VERSA-DIAL HUMERAL HEAD PROSTHESIS

Applicant Biomet Manufacturing Corp

K number K060716

View details →

MBF 2006-05-30

COMPREHENSIVE PRIMARY SHOULDER STEMS

Applicant Biomet Manufacturing Corp

K number K060692

View details →

MBF 2005-02-17

BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS

Applicant Biomet, Inc.

K number K043100

View details →

MBF 2003-11-20

BI-ANGULAR SHOULDER SYSTEM

Applicant Biomet, Inc.

K number K032895

View details →

MBF 2001-08-20

INTERLOK / HA COPELAND RESURFACING HEADS

Applicant Biomet, Inc.

K number K010635

View details →

MBF 2001-07-06

GLOBAL FX POROUS-COATED HUMERAL STEM

Applicant DePuy Orthopaedics, Inc.

K number K011099

View details →

MBF 2001-06-28

GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT

Applicant DePuy Orthopaedics, Inc.

K number K011047

View details →

MBF 1985-01-23

POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS

Applicant Depuy, Inc.

K number K844415

View details →