# K191433: AGILON® XO Shoulder Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Nov 12, 2020 after 533 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K911686 (1991). 157 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 161 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170748: GLOBAL UNITE Platform Shoulder System, Depuy Ireland UC (2018) Summary page 6.
- K183039: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA), Stryker GmbH (2019) Summary page 6.
- K170910: Medacta Anatomic Shoulder Prosthesis, Medacta International S.A. (2017) Summary page 6.
- K170452: Medacta Shoulder System, Medacta International S.A. (2017) Summary page 6.
- K062116: Delta Cta Reverse Shoulder System Humeral Heads, DePuy Orthopaedics, Inc. (2006) Summary page 6.

## Most influential descendants
- K231657: AGILON® XO Shoulder Replacement System (2024), 2 descendants of its own
- K241944: AGILON® XO Shoulder Replacement System (2025), 1 descendant of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## Indications for 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 and 4-fragment fractures (secondary dislocation, material loosening), Posttraumatic humeral head necrosis, Omarthrosis. AGILON® 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 The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint. The provision of prostheses is generally indicated only in patients whose skeleton is fully grown.

Source page: https://510kreport.com/device/K191433
Methodology: https://510kreport.com/methodology