# K191698: TiN Coated Humeral Head

- Pathway: 510(k) (Traditional)
- Applicant: Fx Shoulder USA, Inc.
- Decided: Jul 16, 2020 after 387 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). 120 ancestors in all.
No later device cites it as a predicate yet.
1 of 121 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123814: Humelock II Cemented Shoulder System, Fx Solutions (2013) Summary page 5.
- K163669: Humeris Shoulder, Fx Solutions (2017) Summary page 5.

## Indications for use
When used in the Humelock II Cemented Shoulder System: The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat: 1. Proximal humeral fractures 2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail). The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only. TiN coated Heads are not intended for hemi- shoulder arthroplasty. When used in the Humeris Shoulder System: In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat: - A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis; - Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail). TiN coated Heads are not intended for hemi- shoulder arthroplasty. In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear. The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

Source page: https://510kreport.com/device/K191698
Methodology: https://510kreport.com/methodology