# K081016: Smith & Nephew, Inc., Promos Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 5, 2008 after 149 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K911686 (1991). 23 ancestors in all.
52 later devices descend from it; 6 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063578: Promos Modular Shoulder System, Plus Orthopedics AG (2007) Summary page 4.
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 4.
- K041873: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 4.
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.
- K053274: Anatomical Shoulder Inverse/Reverse, Zimmer GmbH (2006) Summary page 4.

## Most influential descendants
- K110598: SMR Reverse Shoulder System (2011), 44 descendants of its own
- 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

## Recalls of this device
- Nov 21, 2008 · Not classified · Z-0960-2009: The product was breaking during use.
- Nov 21, 2008 · Not classified · Z-0961-2009: The product was breaking during use.

## Indications for use
The PROMOS Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem and body compenents are intended for cementless use. The imptants of the PROMOS Reverse Shoulder System are single u%

Source page: https://510kreport.com/device/K081016
Methodology: https://510kreport.com/methodology