# K213387: AltiVate® Anatomic Shoulder AG e+™ with Markers

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jul 7, 2022 after 266 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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). 114 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203026: AltiVate® Anatomic Pegged Glenoid with Markers, Encore Medical L.P. (2020) Summary page 4.
- K162024: AltiVate Anatomic Shoulder System, Encore Medical L.P. (2016) Summary page 4.

## Most influential descendants
- K222592: AltiVate® Anatomic Shoulder AG e+™ with Markers (2023), 0 descendants of its own

## Indications for use
The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: • Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis • Rheumatoid and other inflammatory arthritis • Correction of functional deformity, including fracture malunion • Humeral head fracture • Revision of other devices if sufficient bone stock remains The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty. Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. Glenoid components are indicated for cemented use only.

Source page: https://510kreport.com/device/K213387
Methodology: https://510kreport.com/methodology