# K110598: SMR Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Aug 18, 2011 after 169 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: 9 generations back to K911686 (1991). 30 ancestors in all.
44 later devices descend from it; 12 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081016: Smith & Nephew, Inc., Promos Reverse Shoulder System, Smith & Nephew, Inc. (2008) Summary page 6.
- K053274: Anatomical Shoulder Inverse/Reverse, Zimmer GmbH (2006) Summary page 6.
- K091751: Depuy Delta Xtend Reverse Shoulder XLK Cup, DePuy Orthopaedics, Inc. (2009) Summary page 6.

## Most influential descendants
- K113254: SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws (2012), 31 descendants of its own
- K133349: SMR TT Metal Back Glenoid (2014), 20 descendants of its own
- K153722: SMR 3-Pegs Glenoids (2016), 13 descendants of its own
- K142139: SMR 40MM Glenosphere (2014), 13 descendants of its own
- K191746: SMR TT Augmented Glenoid System (2019), 12 descendants of its own

## Recalls of this device
- Apr 8, 2016 · Class II · Z-1711-2016: Complaints of intra-operative breakage of the glenosphere impactors/extractors.

## 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 components are intended for use in cemented and uncemented applications, as specified in the following table:

Source page: https://510kreport.com/device/K110598
Methodology: https://510kreport.com/methodology