# K130895: Reunion Rsa Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 27, 2013 after 270 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: 11 generations back to K911686 (1991). 84 ancestors in all.
14 later devices descend from it; 1 cites it directly.
1 of 99 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 4.
- K072804: Comprehensive RS Shoulder System, Biomet Manufacturing Corp (2007) Summary page 4.
- K112069: RSP Glenoid Baseplate Porous Coated, Encore Medical L.P. (2011) Summary page 4.
- K081171: Tritanium Acetabular Shell System, Howmedica Osteonics Corp. (2008) Summary page 4.
- K062250: Delta Xtend Reverse Shoulder System, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 4.

## Most influential descendants
- K161863: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) (2016), 13 descendants of its own
- K172210: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (2017), 10 descendants of its own
- K181742: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (2018), 9 descendants of its own
- K183039: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (2019), 8 descendants of its own
- K191433: AGILON® XO Shoulder Replacement System (2020), 3 descendants of its own

## Indications for use
The ReUnion RSA Shoulder System is intended for primary, fracture, or revision total shoulder replacement. The patient’s joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s). • Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis • Proximal humeral fracture Revision of previously failed shoulder joint replacement • Glenoid Baseplate components are intended for cementless use with the addition of screw fixation. The humeral stem components are intended for both cemented and cementless use.

Source page: https://510kreport.com/device/K130895
Methodology: https://510kreport.com/methodology