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Encore Reverse Shoulder Prosthesis

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051075

by Encore Medical L.P.

Identifiers

510(k) Number
K051075 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 Encore Reverse Shoulder Prosthesis is a reverse shoulder arthroplasty device designed for patients with severe rotator cuff arthropathy or dysfunction. It features an inverted ball-and-socket articulation, where the ball component is fixed to the glenoid baseplate and the cup component to the humeral stem, enabling restored shoulder mobility and function.

This device is intended for cementless fixation of the glenoid baseplate and is supplied as a modular system for surgical implantation. It is regulated under FDA 510(k) clearance (K051075) and is classified under the Orthopedic advisory committee. The prosthesis is intended for use in orthopedic surgical settings and requires proper training for implantation.

Frequently asked questions

What types of shoulder conditions is the Encore Reverse Shoulder Prosthesis specifically designed to address?

The Encore Reverse Shoulder Prosthesis is designed for patients with severe rotator cuff arthropathy or dysfunction. Its inverted ball-and-socket design helps restore shoulder mobility and function in cases where traditional shoulder replacements may not be suitable due to rotator cuff damage or degenerative joint issues.

How is the glenoid component of this prosthesis fixed to the bone, and what does that mean for surgical planning?

The glenoid baseplate of the Encore Reverse Shoulder Prosthesis is intended for cementless fixation, meaning it is designed to integrate directly with the bone without the use of bone cement. This approach requires careful surgical planning to ensure proper bone preparation and alignment for optimal long-term stability.

Is this device modular, and if so, how does that affect surgical flexibility?

Yes, the Encore Reverse Shoulder Prosthesis is supplied as a modular system, allowing surgeons to select and combine different components (e.g., ball, cup, baseplate, and stem) during surgery. This modularity provides flexibility to tailor the implant to the patient’s anatomy and clinical needs, improving precision and customization.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

The Encore Reverse Shoulder Prosthesis received FDA 510(k) clearance (K051075) under a Special 510(k) classification, with a determination of Substantially Equivalent to a predicate device. This means it was reviewed by the FDA’s Orthopedic (OR) Advisory Committee and deemed comparable in safety and effectiveness to existing devices, allowing for its use in orthopedic surgical settings as intended.

Does the device require any special handling or storage conditions before use?

While the provided data does not specify exact storage conditions, reverse shoulder prostheses like this typically require sterile packaging and protection from contamination. Since it is intended for single-use (implied by modular surgical implants), it should be stored in its original, unopened packaging in a clean, dry environment until ready for use, following manufacturer guidelines to maintain sterility.

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: Encore Reverse® Shoulder Prosthesis - Dallas Bone & Joint Clinic, ENCORE REVERSE SHOULDER PROSTHESIS (K041066) — FDA 510(k) | Innolitics, PDF Encore Medical, L.P. 9800 Metric Blvd. Austin, TX 78758

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Encore Medical L.P.

Sources (1)

  • FDA 510(k) K051075 24 fields · synced Sep 19, 2026