# K200368: LINK Embrace Shoulder System - Reverse Configuration

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Feb 5, 2021 after 357 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: 14 generations back to K911686 (1991). 102 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 106 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K181611: Comprehensive Reverse Shoulder System, Biomet Manufacturing Corp (2018) Summary page 4.
- K130390: Comprehensive Convertible Glenoid, Biomet Manufacturing, Inc. (2013) Summary page 4.
- K113069: Comprehensive Reverse Shoulder Humeral Tray, Biomet Manufacturing Corp (2012) Summary page 4.
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 4.
- K132239: Comprehensive Reverse Shoulder Screws, Biomet Manufacturing Corp (2013) Summary page 4.

## Most influential descendants
- K231445: LINK Embrace Shoulder System - Reverse Configuration (2023), 0 descendants of its own
- K212992: LINK® Embrace Shoulder System - Reverse Configuration (2021), 0 descendants of its own
- K210899: LINK Embrace Shoulder System- Anatomical Configuration (2021), 0 descendants of its own

## Indications for use
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 Baseplate 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 are intended for cemented or cementless fixation.

Source page: https://510kreport.com/device/K200368
Methodology: https://510kreport.com/methodology