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K Number
K191433
Device Name
AGILON® XO Shoulder Replacement System
Manufacturer
Implantcast GmbH
Date Cleared
2020-11-12

(533 days)

Product Code
HSD,KWS,MBF,PHX
Regulation Number
888.3690
Type
Traditional
Panel
OR
Reference & Predicate Devices
K170748,K183039,K170910,K170452,K062116
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AGILON® XO Shoulder Replacement System is indicated for use for cementless inverse (reverse) total or hemi shoulder replacement in cases of:

  • Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, .
  • . Post-traumatic osteoarthritis.
  • Fractures,
  • . Rheumatoid arthritis.

The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:

  • Multifragmental comminuted fractures of the humeral head,
  • 3- and 4-Fragment-fractures of the proximal humerus,
  • . Head-splitting fractures,
  • . Dislocated head-splitting fractures,
  • . Humeral head depression with more than 40% of joint surface depressed,
  • . Interlocking chronic dislocation with deep HILL-SACHS lesion,
  • . Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
  • Posttraumatic humeral head necrosis, ●
  • . Omarthrosis.

AGLON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.

The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:

  • . Rotator cuff tear arthropathy,
  • . Chronic trauma shoulder,
  • . Decentering of the humeral head after implantation of a humeral head prosthesis.

Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.

In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:

  • From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty ●
  • . From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
  • From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure ●
  • . From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
Device Description

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with various options depending upon the size and of each patient. The components can be combined into an hemi or reverse shoulder:
Hemi Shoulder:

  • Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap) ●
  • o Humeral Stems (Cementless)
    Reverse Shoulder:
  • Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ●
  • o Glenoid and Glenosphere Components (AGLION® XO Glenoid Baseplate and AGILON® Glenosphere)
  • o Humeral Stems (Cementless)
    Metaphyseal components, stem extension pieces, and component connection fixation screws are intended to be used for hemi and reverse shoulder configurations.
AI/ML Overview

This document describes the AGILON® XO Shoulder Replacement System, a modular shoulder replacement system. However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics typically associated with AI/ML-driven medical devices.

Instead, this document is a 510(k) premarket notification summary for a traditional medical device (shoulder replacement system) and focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "performance testing" section refers to mechanical and material property testing, which is standard for orthopedic implants, not performance studies for an AI/ML algorithm.

Therefore, I cannot populate the requested table and sections regarding acceptance criteria and performance study details for an AI system because that information is not present in the provided text. The document is about a physical implant, not a software device with performance criteria like sensitivity, specificity, or reader improvement.

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.