← Back to catalogue

Reverse Shoulder Monoblock Prosthesis (RSP)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111061

by Encore Medical L.P.

Identifiers

510(k) Number
K111061 FDA 510(k)
FDA Product Code
PHX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3660 FDA 510(k)
Regulation Number
888.3660 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Reverse Shoulder Monoblock Prosthesis (RSP) is a shoulder arthroplasty device classified as a reverse shoulder prosthesis. It is designed to restore function in patients with a functional deltoid muscle and a severely deficient rotator cuff, addressing conditions such as severe arthropathy or failed prior joint replacements.

This device is intended for use in orthopedic surgical settings and is supplied as a sterile, single-use implant. It is regulated under FDA 510(k) clearance (K111061) and is intended for specific indications related to glenohumeral joint pathology. Sizing and implantation follow manufacturer-provided guidelines to ensure proper fit and function.

Frequently asked questions

What types of shoulder conditions is the Reverse Shoulder Monoblock Prosthesis (RSP) specifically designed to address in patients?

The RSP is designed for patients with a functional deltoid muscle but a severely deficient rotator cuff, addressing conditions like severe arthropathy (joint degeneration) or failed prior shoulder joint replacements. It helps restore function in these cases by providing an alternative mechanical advantage through its reverse shoulder design.

Is the Reverse Shoulder Monoblock Prosthesis (RSP) intended for reuse, or is it meant to be used only once per patient?

The RSP is explicitly supplied as a sterile, single-use implant, meaning it is intended for one-time surgical use per patient. Reuse is not recommended or supported by the manufacturer, as this could compromise sterility and patient safety.

How is the sizing of the Reverse Shoulder Monoblock Prosthesis (RSP) determined during surgery, and what guidance does the manufacturer provide?

Sizing for the RSP follows manufacturer-provided guidelines to ensure a proper fit and function. While exact measurements aren’t detailed here, the device is designed to be implanted based on preoperative planning and intraoperative assessment, typically using templating or measurement tools to match the patient’s glenohumeral anatomy.

What regulatory pathway was followed for the FDA clearance of the Reverse Shoulder Monoblock Prosthesis (RSP), and what does this mean for its use?

The RSP received FDA clearance through a 510(k) pathway (K111061), specifically classified under Special 510(k) with a Substantially Equivalent (SESE) determination. This means the device was deemed comparable to a legally marketed predicate device in terms of technology and safety, allowing it to enter the market under this regulatory route.

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: PDF Encore Medical, L.P. 9800 Metric Blvd. Austin, TX 78758, REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) (K111061) — FDA 510(k ..., K130048 FDA 510 (k) - REVERSE SHOULDER PROSTHESIS MONOBLOCK

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Encore Medical L.P.

Sources (1)

  • FDA 510(k) K111061 24 fields · synced Sep 19, 2026