# K212992: LINK® Embrace Shoulder System - Reverse Configuration

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Nov 18, 2021 after 59 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: 17 generations back to K911686 (1991). 146 ancestors in all.
No later device cites it as a predicate yet.
1 of 147 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.
- K110598: SMR Reverse Shoulder System, Lima Corporate S.P.A. (2011) Summary page 4.
- K100858: Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies,, Lima-Lto S.P.A. (2010) Summary page 4.
- K101263: Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System - Finned Humeral Bodies,, Lima-Lto S.P.A. (2011) Summary page 4.
- K173717: Integra TITAN Reverse Shoulder System, Integra LifeSciences Corporation (2018) Summary page 4.
- K181999: Integra TITAN Reverse Shoulder System, Integra LifeSciences Corporation (2018) Summary page 4.
- K190588: Integra TITAN Reverse Shoulder System, Integra LifeSciences Corporation (2019) 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) and Short 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 75mm 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/K212992
Methodology: https://510kreport.com/methodology