MBF · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Orthopedic · 21 CFR 888.3670 · Class 2
Overview
| Product Code | MBF |
|---|---|
| Device Name | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
| Regulation | 21 CFR 888.3670 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
Cleared Devices (37)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Zimmer, Inc. | Apr 13, 2026 | SESE |
| K251098 | Identity Revision Humeral Stems | Zimmer, Inc. | Aug 11, 2025 | SESE |
| K250848 | Identity Shoulder System | Zimmer, Inc. | Jul 2, 2025 | SESE |
| K240876 | Identity Shoulder System | Zimmer, Inc. | Jun 12, 2024 | SESE |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | Jan 11, 2024 | SESE |
| K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | Dec 21, 2023 | SESE |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | Nov 13, 2023 | SESE |
| K231516 | INHANCE Shoulder System, Sterile Single Use Instrumentation | Depuy Ireland UC | Jul 21, 2023 | SESE |
| K223876 | SMR Shoulder System | Lima Corporate S.P.A. | Feb 3, 2023 | SESE |
| K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | Oct 6, 2022 | SESE |
| K213856 | Identity Shoulder System | Zimmer, Inc. | Sep 15, 2022 | SESE |
| K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | Depuy Ireland UC | Jun 8, 2022 | SESE |
| K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | May 19, 2022 | SESE |
| K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | May 20, 2021 | SESE |
| K201905 | SMR 140° Reverse Humeral Body | Lima Corporate S.P.A. | Dec 17, 2020 | SESE |
| K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | Oct 28, 2020 | SESE |
| K191963 | SMR Finned Short Stems | Lima Corporate S.P.A. | Oct 10, 2019 | SESE |
| K183553 | Compress and Mini Compress Anti-Rotation Spindles | Biomet, Inc. | Jan 22, 2019 | SESE |
| K173824 | Humeral Short Stem System | Shoulder Innovations, Inc. | Oct 23, 2018 | SESE |
| K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | Jun 29, 2017 | SESE |
| K162068 | ARROW Anatomical Porous glenoid | Fournitures Hospitalieres Industrie | Apr 10, 2017 | SESE |
| K140390 | TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS | Biomet Manufacturing Corp | Sep 10, 2014 | SESE |
| K130126 | SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM | Biomet, Inc. | Aug 6, 2013 | SESE |
| K123297 | COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM | Biomet Manufactuting Corp. | Nov 20, 2012 | SESE |
| K112905 | COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM | Biomet Orthopedics, LLC | May 24, 2012 | SESE |
| K083439 | SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM | Synthes (Usa) | Feb 5, 2009 | SESE |
| K081448 | ENCORE SHOULDER REVISION GLENOID | Encore Medical L.P. | Sep 30, 2008 | SESE |
| K070565 | COFIELD TOTAL SHOULDER SYSTEM | Smith & Nephew, Inc. | May 18, 2007 | SESE |
| K063652 | GLOBAL AP POROUS COATED HUMERAL STEM | DePuy Orthopaedics, Inc. | Feb 1, 2007 | SESE |
| K060716 | VERSA-DIAL HUMERAL HEAD PROSTHESIS | Biomet Manufacturing Corp | Jun 12, 2006 | SESE |
| K060692 | COMPREHENSIVE PRIMARY SHOULDER STEMS | Biomet Manufacturing Corp | May 30, 2006 | SESE |
| K043100 | BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS | Biomet, Inc. | Feb 17, 2005 | SESE |
| K032895 | BI-ANGULAR SHOULDER SYSTEM | Biomet, Inc. | Nov 20, 2003 | SESE |
| K010635 | INTERLOK / HA COPELAND RESURFACING HEADS | Biomet, Inc. | Aug 20, 2001 | SESE |
| K011099 | GLOBAL FX POROUS-COATED HUMERAL STEM | DePuy Orthopaedics, Inc. | Jul 6, 2001 | SESE |
| K011047 | GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT | DePuy Orthopaedics, Inc. | Jun 28, 2001 | SESE |
| K844415 | POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS | Depuy, Inc. | Jan 23, 1985 | SESE |
Top Applicants
- Lima Corporate S.P.A. — 8 clearances
- Zimmer, Inc. — 5 clearances
- Biomet, Inc. — 5 clearances
- Biomet Manufacturing Corp — 4 clearances
- Depuy Ireland UC — 3 clearances
