Hemi-Shoulder Prosthesis (HSD)

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Hemi-Shoulder Prosthesis

510(k) Number

K950594 ↗

FDA Product Code

HSD

Device Class

Class II

Regulation

21 CFR Part 888.3690

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 6.5 Mm Cancellous Bone Screw

  Class II

  FDA 510(k) K931665 Active Cleared 17 Feb 1994

• Berlin External Fixator

  Class II

  FDA 510(k) K954053 Active Cleared 16 May 1996

• Modification to Isobar Spinal System

  Class II

  FDA 510(k) K000020 Active Cleared 3 Feb 2000

• Foundation Knee Augmentation Blocks

  Class II

  FDA 510(k) K941306 Active Cleared 8 Feb 1995

• Foundation Porous Coated Hemispherical Shell

  Class II

  FDA 510(k) K974093 Active Cleared 28 Jan 1998

• Press-Fit Porous Shell

  Class II

  FDA 510(k) K961526 Active Cleared 17 Sep 1996

See all devices from Encore Orthopedics, Inc. →

• What is the Hemi-Shoulder Prosthesis HSD designed for?

  The Hemi-Shoulder Prosthesis (HSD) is designed to replace the damaged articular surface of the humeral head in shoulder arthroplasty procedures. It is intended for patients requiring restoration of shoulder function due to conditions like fractures, arthritis, or degenerative joint disease. The uncemented design ensures secure fixation within the bone without the need for bone cement, reducing risks associated with cement use.

• How is the Hemi-Shoulder Prosthesis HSD supplied and prepared for use?

  The HSD is supplied sterile and intended for single-use only. It must be handled according to sterile medical device protocols to maintain its integrity and sterility. The packaging ensures it remains uncontaminated until implantation, adhering to FDA guidelines for sterile orthopedic implants.

• What material is the Hemi-Shoulder Prosthesis HSD made from, and why?

  The HSD is constructed from cobalt-chromium-molybdenum alloys, a durable and biocompatible material chosen for its strength, corrosion resistance, and ability to withstand the mechanical stresses of the shoulder joint. This material also reduces the risk of allergic reactions or adverse tissue responses, ensuring long-term stability and performance.

• Does the HSD require special storage conditions?

  Yes, the HSD must be stored in accordance with sterile medical device protocols to preserve its sterility and functionality. This includes keeping it in its original packaging, away from direct sunlight or extreme temperatures, and ensuring it is not exposed to moisture or contaminants. Proper storage is critical to prevent degradation and maintain compliance with FDA regulations for orthopedic implants.

• What regulatory pathway does the HSD follow, and what does that mean for clinicians?

  The HSD follows the FDA’s 510(k) clearance pathway with a Substantially Equivalent (SESE) determination, meaning it has been evaluated and deemed comparable to a legally marketed predicate device. Clinicians can rely on this clearance as evidence of the device’s safety and effectiveness for its intended use in shoulder arthroplasty, though they should always follow local protocols and guidelines for implantation.