# K172351: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Oct 30, 2017 after 88 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 3 (0 Class I)
- 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.
18 later devices descend from it; 7 cite it directly.
1 of 165 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141990: Encore Humeral Shoulder Stem, Encore Medical L.P. (2014) Summary page 6.
- K100741: Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012, Encore Medical L.P. (2010) Summary page 6.
- K111061: Reverse Shoulder Monoblock Prosthesis (RSP), Encore Medical L.P. (2011) Summary page 6.
- K111735: Reverse Shoulder Prosthesis Monoblock Hemi Adapter, Encore Medical L.P. (2011) Summary page 6.
- K141006: RSP Humeral Socket Insert, Djo Global (2014) Summary page 6.
- K052906: Zimmer Trabecular Metal Reverse Shoulder System, Zimmer, Inc. (2005) Summary page 6.

## Most influential descendants
- K190290: AltiVate Reverse Humeral Stem, 48mm (2019), 15 descendants of its own
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System (2021), 5 descendants of its own
- K211991: Catalyst R1 Reverse Shoulder System (2021), 3 descendants of its own
- K213349: Catalyst R1 Reverse Shoulder System (2022), 2 descendants of its own
- K212800: PRIMA Humeral System and SMR Glenosphere Ø42 (2022), 2 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0281-2024: Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
- Aug 4, 2023 · Class II · Z-2607-2023: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, 
- Aug 31, 2020 · Class II · Z-0117-2021: Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.

## Indications for use
Indications for AltiVate™ Stem: Anatomic Total Shoulder Indications: The AltiVate™ Shoulder Prosthesis Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: * Noninflammatory degenerative joint disease including osteoarthritis; * Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis; * Post-traumatic arthritis of the glenohumeral joint; * Avascular necrosis of the humeral head with and without involvement of the glenoid,; * Correction of functional deformity The all-poly glenoid is intended for cemented use Hemi Shoulder Indications: The AltiVate™ Shoulder Prosthesis Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to: * Noninflammatory degenerative joint disease including osteoarthritis; * Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis; * Post-traumatic arthritis of the glenohumeral joint; * Avascular necrosis of the humeral head with and without involvement of the glenoid,; * Correction of functional deformity; * Rotator cuff tear arthropathy; * Humeral fracture. * Failed previous shoulder surgery Reverse Total Shoulder Indications: The AltiVate™ Shoulder Prosthesis Stem is 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 humeral stems are intended for cemented or cementless use.

Source page: https://510kreport.com/device/K172351
Methodology: https://510kreport.com/methodology