Humeral Eccentric Reverse Metaphysis (K210207)

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

Full name

Humeral Eccentric Reverse Metaphysis

510(k) Number

K210207 ↗

FDA Product Code

PHX

Device Class

Class II

Regulation

21 CFR Part 888.3660

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Humeral Eccentric Reverse Metaphysis in shoulder surgery?

  The Humeral Eccentric Reverse Metaphysis is specifically designed for reverse shoulder arthroplasty procedures. Its eccentric metaphyseal fit and 3 mm offset are intended to aid in humeral reconstruction, providing a secure foundation for the humeral component while ensuring proper alignment and stability during surgery.

• Is this device reusable or intended for single-use only, and how is it supplied?

  The Humeral Eccentric Reverse Metaphysis is supplied as a sterile, single-use implant. It is not intended for reuse, and each component is packaged to maintain sterility for one-time surgical use, adhering to regulatory standards like 21 CFR 888.3660.

• What materials is the device made from, and how is it assembled?

  The device is constructed from Ti-6Al-4V titanium alloy, a durable material commonly used in orthopedic implants for its strength and biocompatibility. It consists of a metaphysis component and a screw, which are assembled via a cylindrical driven-fit coupling and secured with the screw for diaphyseal fixation during surgery.

• How should this device be stored before use, and what precautions should be taken?

  Since the device is sterile and single-use, it should be stored in its original packaging until immediately before use, following the manufacturer’s instructions to preserve sterility. Avoid exposure to moisture, extreme temperatures, or contamination, as these could compromise its integrity or sterility.

• What regulatory pathway was followed for FDA clearance, and when was the decision made?

  The Humeral Eccentric Reverse Metaphysis received FDA 510(k) clearance under the Traditional review pathway, with a decision date of March 26, 2021. The submission was classified under the Orthopedic (OR) advisory committee and was determined to be Substantially Equivalent (SESE) to a predicate device.