# K222592: AltiVate® Anatomic Shoulder AG e+™ with Markers

- Pathway: 510(k) (Abbreviated)
- Applicant: Encore Medical L.P.
- Decided: Jun 23, 2023 after 301 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: 15 generations back to K911686 (1991). 146 ancestors in all.
No later device cites it as a predicate yet.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213387: AltiVate® Anatomic Shoulder AG e+™ with Markers, Encore Medical L.P. (2022) Summary page 4.
- K103419: Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM, Exactech, Inc. (2010) Summary page 4.
- K111379: Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large / Extra-Large, Left / Right, Exactech, Inc. (2011) Summary page 4.
- K121220: Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right, Exactech, Inc. (2012) Summary page 4.

## 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/K222592
Methodology: https://510kreport.com/methodology