# K162024: AltiVate Anatomic Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Nov 21, 2016 after 122 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K911686 (1991). 110 ancestors in all.
34 later devices descend from it; 8 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080402: Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model 520-38, Encore Medical L.P. (2008) Summary page 5.
- K123982: Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+, Encore Medical L.P. (2013) Summary page 5.
- K140904: RSP Monoblock Stem with P2 Coating, Size 6, Encore Medical L.P. (2014) Summary page 5.
- K113413: Ascend Shoulder System, Tornier, Inc. (2012) Summary page 5.

## Most influential descendants
- K190290: AltiVate Reverse Humeral Stem, 48mm (2019), 15 descendants of its own
- K202716: Ignite Anatomic Shoulder System (2021), 13 descendants of its own
- K212737: INHANCE™ Reverse Shoulder System (2022), 9 descendants of its own
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System (2021), 5 descendants of its own
- K193226: AltiVate Anatomic Canal-Sparing (CS) Shoulder (2020), 4 descendants of its own

## Recalls of this device
- Jun 28, 2021 · Class II · Z-2331-2021: Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.
- Jan 29, 2018 · Class II · Z-1258-2018: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is
- Jan 29, 2018 · Class II · Z-1260-2018: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is
- Jan 29, 2018 · Class II · Z-1256-2018: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is
- Jan 29, 2018 · Class II · Z-1257-2018: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is
- Jan 29, 2018 · Class II · Z-1259-2018: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is

## 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 AltiVate Anatomic™ Shoulder System is a hemiarthroplasty shoulder replacement for patients with a functional deltoid muscle 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 • Rotator cuff tear arthropathy • 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/K162024
Methodology: https://510kreport.com/methodology