# K210899: LINK Embrace Shoulder System- Anatomical Configuration

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Jun 21, 2021 after 87 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- 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). 107 ancestors in all.
No later device cites it as a predicate yet.
1 of 108 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161476: SMR Shoulder System, Lima Corporate S.P.A. (2016) Summary page 4.
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 4.
- K200368: LINK Embrace Shoulder System - Reverse Configuration, Waldemar Link GmbH & Co. KG (2021) Summary page 4.

## Indications for use
General indications: The LINK Embrace Shoulder System - Anatomic Configuration is intended for anatomic total or hemi shoulder arthroplasty. Indications: • A severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis • Avascular necrosis of the humeral head • Deformity and/or limited motion • Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory • Revision of a failed primary component • Ununited humeral head fractures • Cuff tear arthropathy (CTA Heads only) The All Poly Glenoid Components are intended for cemented use. 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/K210899
Methodology: https://510kreport.com/methodology