# K103208: Reverse Shoulder Prosthesis Monoblock Stem

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jan 31, 2011 after 91 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K911686 (1991). 38 ancestors in all.
59 later devices descend from it; 3 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082120: Aequalis Reversed Fracture Shoulder Prothesis, Tornier (2008) Summary page 4.

## Most influential descendants
- 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
- K141990: Encore Humeral Shoulder Stem (2014), 19 descendants of its own

## Indications for use
The Reverse Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint: In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus. In cases of bone defect in proximal humerus. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s). 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/K103208
Methodology: https://510kreport.com/methodology