# K233481: AltiVate Reverse® Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: May 29, 2024 after 216 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K911686 (1991). 36 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 5.
- K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 5.
- K092873: Reverse Shoulder Prosthesis, Djo Surgical (2009) Summary page 5.
- K112069: RSP Glenoid Baseplate Porous Coated, Encore Medical L.P. (2011) Summary page 5.
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Tornier, Inc. (2016) Summary page 5.

## Most influential descendants
- K253592: Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (2026), 0 descendants of its own
- K252567: AltiVate Reverse® ADLC Glenosphere (2026), 0 descendants of its own
- K252141: AltiVate Reverse® Glenoid (2025), 0 descendants of its own
- K251184: AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System (2025), 0 descendants of its own

## Recalls of this device
- Jul 18, 2025 · Class II · Z-2548-2025: Their is a potential that the reamer may kick or bind up during or immediately prior to use.
- Jul 18, 2025 · Class II · Z-2546-2025: Their is a potential that the reamer may kick or bind up during or immediately prior to use.
- Jul 18, 2025 · Class II · Z-2549-2025: Their is a potential that the reamer may kick or bind up during or immediately prior to use.
- Jul 18, 2025 · Class II · Z-2547-2025: Their is a potential that the reamer may kick or bind up during or immediately prior to use.
- May 28, 2025 · Class II · Z-2011-2025: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- May 28, 2025 · Class II · Z-2010-2025: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- May 28, 2025 · Class II · Z-2008-2025: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- May 28, 2025 · Class II · Z-2009-2025: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

## 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/K233481
Methodology: https://510kreport.com/methodology