# K252567: AltiVate Reverse® ADLC Glenosphere

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jan 15, 2026 after 154 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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: 11 generations back to K911686 (1991). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 5.
- K092873: Reverse Shoulder Prosthesis, Djo Surgical (2009) Summary page 5.
- K233481: AltiVate Reverse® Glenoid, Encore Medical L.P. (2024) Summary page 5.

## Indications for use
The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: • Severe arthropathy with a grossly deficient rotator cuff; • Previously failed joint replacement with a grossly deficient rotator cuff; • Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; • Bone defect in proximal humerus; • Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; • Inflammatory arthritis including rheumatoid arthritis; • Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

Source page: https://510kreport.com/device/K252567
Methodology: https://510kreport.com/methodology