Osteonics All Polyethylene Glenoid Shoulder Component

• • Ongoing Z-3200-2026 FDA Class II ·initiated 30 Jul 2026

  Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

510(k) Number

K962082 ↗

FDA Product Code

KWS

Device Class

Class II

Regulation

21 CFR Part 888.3660

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K870235 Active Cleared 29 May 1987

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See all devices from Osteonics Corp. →

• What is the primary clinical use of the Osteonics All Polyethylene Glenoid Shoulder Component?

  This device is intended for use in total shoulder arthroplasty. It functions as a glenoid resurfacing component, which is implanted into the surgically prepared glenoid fossa to restore joint function.

• What material is used to manufacture this glenoid component?

  The component is constructed from ultra-high molecular weight polyethylene. This material is chosen for its durability and suitability for orthopedic prosthetic applications.

• How is this glenoid component secured during surgery?

  The device is designed to be used with bone cement. The surgeon applies the cement to the prepared glenoid fossa to fix the polyethylene component securely in place.

• Does this shoulder component feature any joint linkage?

  No, this specific glenoid resurfacing component features no linkage across the joint. It is designed as a standalone resurfacing implant for the glenoid side of the shoulder joint.

• What is the regulatory status of this device?

  The Osteonics All Polyethylene Glenoid Shoulder Component has received FDA 510(k) clearance under the number K962082, confirming it has been found substantially equivalent to predicate devices.