# K193226: AltiVate Anatomic Canal-Sparing (CS) Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jun 3, 2020 after 194 days
- Product code: PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained)
- 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: 13 generations back to K911686 (1991). 116 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143552: Simpliciti Shoulder System, Tornier, Inc. (2015) Summary page 4.
- K162024: AltiVate Anatomic Shoulder System, Encore Medical L.P. (2016) Summary page 4.

## Most influential descendants
- K203108: Ignite Stemless Anatomic Shoulder System (2021), 3 descendants of its own
- K243248: Inhance Intact™ (2024), 0 descendants of its own
- K230831: INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (2023), 0 descendants of its own
- K223211: INHANCETM Shoulder System – Humeral Stems and Stemless (2022), 0 descendants of its own

## Indications for use
The AltiVate® Anatomic CS Shoulder is indicated for severely painful and/or disabled shoulder joint resulting from osteoarthritis or traumatic arthritis. The humeral components with a porous coated surface are indicated for uncemented (press-fit) applications. Glenoid components are indicated for cemented use only.

Source page: https://510kreport.com/device/K193226
Methodology: https://510kreport.com/methodology