# K051075: Encore Reverse Shoulder Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: May 27, 2005 after 30 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041066 (2005). 1 ancestor in all.
248 later devices descend from it; 19 cite it directly.
1 of 250 devices in its family (counting itself) has 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 1.

## Most influential descendants
- K052086: Encore Reverse Shoulder Prosthesis Humeral Stem Adapter (2005), 201 descendants of its own
- K063569: Equinoxe Reverse Shoulder System (2007), 190 descendants of its own
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw (2008), 177 descendants of its own
- K072804: Comprehensive RS Shoulder System (2007), 175 descendants of its own
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own

## Recalls of this device
- Jan 15, 2026 · Class II · Z-1460-2026: Knee and Humeral socket implants contain incorrect labeling.
- Oct 5, 2023 · Class II · Z-0625-2024: Mislabeling
- Sep 25, 2023 · Class II · Z-0282-2024: 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-2606-2023: 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, 
- Apr 18, 2011 · Not classified · Z-2739-2011: The device has the potential to not appropriately mate with the humeral stem.

## Indications for use
The Encore Reverse Shoulder Prosthesis® (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

Source page: https://510kreport.com/device/K051075
Methodology: https://510kreport.com/methodology