Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3670](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3670) → MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented # MBF · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented _Orthopedic · 21 CFR 888.3670 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF ## Overview - **Product Code:** MBF - **Device Name:** Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented - **Regulation:** [21 CFR 888.3670](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3670) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **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.” ## Recent Cleared Devices (20 of 37) Showing 20 most recent of 37 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253592](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K253592.md) | 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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K251098.md) | Identity Revision Humeral Stems | Zimmer, Inc. | Aug 11, 2025 | SESE | | [K250848](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K250848.md) | Identity Shoulder System | Zimmer, Inc. | Jul 2, 2025 | SESE | | [K240876](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K240876.md) | Identity Shoulder System | Zimmer, Inc. | Jun 12, 2024 | SESE | | [K233712](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K233712.md) | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | Jan 11, 2024 | SESE | | [K231099](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K231099.md) | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | Dec 21, 2023 | SESE | | [K230831](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K230831.md) | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | Nov 13, 2023 | SESE | | [K231516](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K231516.md) | INHANCE™ Shoulder System, Sterile Single Use Instrumentation | Depuy Ireland UC | Jul 21, 2023 | SESE | | [K223876](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K223876.md) | SMR Shoulder System | Lima Corporate S.P.A. | Feb 3, 2023 | SESE | | [K222427](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K222427.md) | PRIMA TT Glenoid | Lima Corporate S.P.A. | Oct 6, 2022 | SESE | | [K213856](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K213856.md) | Identity Shoulder System | Zimmer, Inc. | Sep 15, 2022 | SESE | | [K212933](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K212933.md) | INHANCETM Hybrid Anatomic Glenoid Implant | Depuy Ireland UC | Jun 8, 2022 | SESE | | [K220792](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K220792.md) | SMR Reverse Liner | Lima Corporate S.P.A. | May 19, 2022 | SESE | | [K202716](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K202716.md) | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | May 20, 2021 | SESE | | [K201905](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K201905.md) | SMR 140° Reverse Humeral Body | Lima Corporate S.P.A. | Dec 17, 2020 | SESE | | [K193038](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K193038.md) | Comprehensive Shoulder System | Biomet Manufacturing Corp | Oct 28, 2020 | SESE | | [K191963](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K191963.md) | SMR Finned Short Stems | Lima Corporate S.P.A. | Oct 10, 2019 | SESE | | [K183553](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K183553.md) | Compress and Mini Compress Anti-Rotation Spindles | Biomet, Inc. | Jan 22, 2019 | SESE | | [K173824](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K173824.md) | Humeral Short Stem System | Shoulder Innovations, Inc. | Oct 23, 2018 | SESE | | [K163397](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF/K163397.md) | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | Jun 29, 2017 | SESE | ## Top Applicants - Lima Corporate S.P.A. — 8 clearances - Biomet, Inc. — 5 clearances - Zimmer, Inc. — 5 clearances - Biomet Manufacturing Corp — 4 clearances - DePuy Orthopaedics, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com