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The Easytech® Anatomical Shoulder System is in total shoulder repacement to treat a severely painf il and/or disabled joint resulting from osteoarthritis.

The humeral stemless of the Easytech® Anatomical Shoulder is intended for cementless use only. The glencid components of the Easytech® Anatomical Shoulder System are intended for cemented use only.

The patient's joint must be anatomically suited to receive the selected implants and a functional rotator cuff is necessary to use the device.

The Easytech® Anatomical Shoulder is an anatomical shoulder prothesis designed for use in patients with a functional rotator cuff. The Easytech® humeral stemless (Anchor base) is used with a connector, a centered or offset humeral head, and a glenoid for use in an anatomical shoulder configuration.

This system is designed to articulate with a glenoid component for total shoulder arthroplasty. Subject of this submission is the cementless, stemless Humeral Anchor base that is part of the Easytech® Anatomical Shoulder System. The compatible components to complete the system have been cleared previously in K111097, K123814, and K163669.

The Easytech® Anchor base is a stemless prosthesis. The cementless Anchor base is available in diameters of 30 to 38 mm. The Anchor base has a main central post with striaes. In the periphery of the Anchor base, five retentives striaes are positioned to help with the primary fixation. The undersurface of the Anchor base, including the central post and retentive striaes, has a plasma sprayed CPTitanium and Hydroxyapatite coating without the superior surface and the female taper. The Anchor base incorporates a female taper for attachment of compatible components. This component is manufactured in Ti-6AI-4V ELI allov conforming to ISO 5832-3.

The Anchor base can be used with a straight taper connector or a centered spacer manufactured from Ti-6Al-4V ELI alloy conforming to ISO 5832-3, a centered or offset humeral head manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and a 2 pegs or 3 or 4 pegs cemented glenoid manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2 for use in an anatomical shoulder configuration.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

• Adjusted Constant Score >54 AND improved from baseline >10
• No migration or subsidence
• No radiolucencies of the humeral or glenoid components
• Implant integrity maintained
• No revision surgery
• No serious adverse device event | 91.7% (with a lower two-sided 90% confidence bound of 87.3%).
  This is compared to a performance goal for the predicate device of 92.3% and a reference margin of 10%. The lower bound (87.3%) being greater than (92.3% - 10% = 82.3%) indicated success. |
  | Adjusted Constant Score Improvement: Clinically significant improvement in Adjusted Constant Score from preoperative baseline. | Average Month 24+ Adjusted Constant Score: 99.14 (SD 18.73).
  Clinically significant improvement (p

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