# K113523: Limacorporate SMR Reverse Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Lima Corporate S.P.A.
- Decided: Dec 20, 2011 after 21 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). 31 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110598: SMR Reverse Shoulder System, Lima Corporate S.P.A. (2011) Summary page 4.

## Most influential descendants
- K130050: Titan Reverse Shoulder System (2013), 9 descendants of its own
- K161189: Integra TITAN Reverse Shoulder System (2016), 8 descendants of its own
- K190588: Integra TITAN Reverse Shoulder System (2019), 4 descendants of its own
- K173717: Integra TITAN Reverse Shoulder System (2018), 3 descendants of its own
- K181999: Integra TITAN Reverse Shoulder System (2018), 2 descendants of its own

## Indications for use
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The SMR Reverse Shoulder System humeral bodies, cemented non-finned humeral stems and cemented revision stems are intended for cemented use. The SMR Reverse Shoulder System humeral bodies, finned humeral stems and uncemented revision stems are intended for cementless use. The SMR Reverse Shoulder System metal-backed glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation.

Source page: https://510kreport.com/device/K113523
Methodology: https://510kreport.com/methodology