# K231445: LINK Embrace Shoulder System - Reverse Configuration

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Nov 16, 2023 after 182 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K911686 (1991). 123 ancestors in all.
No later device cites it as a predicate yet.
1 of 124 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200368: LINK Embrace Shoulder System - Reverse Configuration, Waldemar Link GmbH & Co. KG (2021) Summary page 4.
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Tornier, Inc. (2016) Summary page 4.
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 4.
- K120121: Comprehensive Reverse Shoulder-Mini Baseplate, Biomet, Inc. (2012) Summary page 4.
- K172502: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate, Biomet Manufacturing Corp (2018) Summary page 4.
- K130129: Univers Revers Shoulder Prosthesis System, Arthrex, Inc. (2013) Summary page 4.
- K142863: Univers Rivers Shoulder Prosthesis System, Arthrex, Inc. (2014) Summary page 4.

## Indications for use
General Indications: The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty. Indications: * Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient’s joint must be anatomically and structurally suited to receive the implants. The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws. The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation. The Humeral Stems Standard without CaP (HX) are intended for cemented or cementless fixation. The Humeral Fracture Stems and Proximal Bodies are intended for cemented or cementless fixation. The Modular Stems 75 mm are intended for cemented or cementless fixation. The Modular Stems, fully corundum blasted, are intended for cementless fixation. The Modular Stems, fully polished, are intended for cemented fixation.

Source page: https://510kreport.com/device/K231445
Methodology: https://510kreport.com/methodology