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Bipolar Shoulder Prosthesis-Shell (rd-113130 +5 more)

FDA 510(k)

Class III (US FDA 510(k))

510(k) K960363

by Biomet, Inc.

Identifiers

510(k) Number
K960363 FDA 510(k)
FDA Product Code
MJT FDA 510(k)
Models / Variants
rd-113130 FDA 510(k)
33 FDA 510(k)
Biangular Modular Head(rd-113101 FDA 510(k)
41 FDA 510(k)
42 FDA 510(k)
Biomodular Modular Head(rd-113143 FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Advisory Committee
Unknown FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder), classified as a metal/polymer construct designed for cemented or uncemented fixation. It features a bipolar shoulder prosthesis-shell with modular head options, including biangular and biomodular configurations, intended for partial or total shoulder arthroplasty to restore function and alleviate pain in degenerative or traumatic shoulder conditions.

The system is supplied sterile and intended for single-use in orthopedic surgical settings. Components include the RD-113130/33 shell paired with modular heads (RD-113101/41/42 or RD-113143), with MRI safety classified as non-MRI conditional. Storage requires adherence to manufacturer guidelines for sterile packaging integrity. Authorized under FDA 510(k) clearance (K960363) as substantially equivalent, it falls under FDA Product Code MJT.

Frequently asked questions

What types of shoulder conditions is this bipolar shoulder prosthesis designed to address, and how does it restore function?

This bipolar shoulder prosthesis-shell is specifically designed for partial or total shoulder arthroplasty to address degenerative or traumatic shoulder conditions. It helps restore function and alleviate pain by replacing damaged shoulder joint surfaces with a metal/polymer construct that allows for smoother articulation and improved mobility. The modular head options (biangular or biomodular) further customize the fit to the patient’s anatomy, enhancing stability and range of motion.

Is this device intended for cemented or uncemented fixation, and how does that affect its use?

The device is designed for both cemented and uncemented fixation, giving surgeons flexibility depending on the patient’s bone quality and clinical needs. Cemented fixation uses bone cement to secure the prosthesis, while uncemented fixation relies on the shell’s surface design to integrate with the bone over time. The choice depends on factors like patient age, bone density, and surgeon preference.

What modular components are included with this bipolar shoulder prosthesis, and how do they differ?

The system includes a bipolar shoulder prosthesis-shell (RD-113130/33) paired with modular heads: biangular heads (RD-113101/41/42) and a biomodular head (RD-113143). The biangular heads offer adjustable neck angles to match the patient’s anatomy, while the biomodular head provides additional customization with modular neck options, allowing for precise alignment and function restoration.

How is this device supplied, and what storage precautions should be taken to maintain sterility?

The device is supplied sterile and intended for single-use in orthopedic surgical settings. To maintain sterility, storage must adhere to the manufacturer’s guidelines, ensuring the sterile packaging remains intact and undamaged. Avoid exposure to moisture, extreme temperatures, or contamination before use.

Can this prosthesis be used in patients who require MRI scans, and if so, what limitations apply?

This device is classified as non-MRI conditional, meaning it is not safe for MRI imaging under any circumstances. Patients with this prosthesis should avoid MRI scans to prevent potential heating, mechanical damage, or other risks associated with magnetic fields. Always verify MRI safety with the manufacturer before imaging.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bipolar Shoulder Prosthesis-shell (Rd-113130/33, Biangular Modular Head ..., PDF K960363 Bipolar Shoulder Prosthesis-shell(Rd-113130/33, Biangular ..., Device Listing 1718918488 - FDA.report, FDA Product Code MJT - Prosthesis, Shoulder, Humeral (bipolar Hemi ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K960363 24 fields · synced Sep 18, 2026