# K112069: RSP Glenoid Baseplate Porous Coated

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Nov 15, 2011 after 118 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). 7 ancestors in all.
74 later devices descend from it; 6 cite it directly.
0 of 82 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.
- K072888: Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and Flared), Encore Medical L.P. (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
- 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
- K172351: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert (2017), 18 descendants of its own

## Recalls of this device
- Sep 6, 2023 · Class II · Z-0532-2024: Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver

## Indications for use
The Reverse Shoulder 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/K112069
Methodology: https://510kreport.com/methodology