# K100741: Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Aug 2, 2010 after 139 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K041066 (2005). 3 ancestors in all.
65 later devices descend from it; 7 cite it directly.
0 of 69 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 4.
- K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.
- K092873: Reverse Shoulder Prosthesis, Djo Surgical (2009) Summary page 4.

## Most influential descendants
- K130048: Reverse Shoulder Prosthesis Monoblock (2013), 59 descendants of its own
- K140904: RSP Monoblock Stem with P2 Coating, Size 6 (2014), 55 descendants of its own
- K162024: AltiVate Anatomic Shoulder System (2016), 34 descendants of its own
- K141006: RSP Humeral Socket Insert (2014), 21 descendants of its own
- K151293: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis (2015), 20 descendants of its own

## Recalls of this device
- Jan 15, 2026 · Class II · Z-1458-2026: Knee and Humeral socket implants contain incorrect labeling.

## Indications for use
For treatment of patlents 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/K100741
Methodology: https://510kreport.com/methodology