# K103835: Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) Reunion Tsa System N

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 5, 2011 after 126 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 4 generations back to K943462 (1994). 22 ancestors in all.
43 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955731: Osteonics Shoulder Humeral Components, Osteonics Corp. (1996) Summary page 1.
- K062113: Solar Reunion Fracture Stem, Howmedica Osteonics Corp. (2006) Summary page 1.
- K950521: Osteonics All  Polyethylene Glenoid Shoulder Component, Osteonics Corp. (1995) Summary page 1.
- K962082: Osteonics All Polyethylene Glenoid Shoulder Component, Osteonics Corp. (1996) Summary page 1.
- K001419: Solar Shoulder Offset Humeral Head, Howmedica Osteonics Corp. (2000)
- K990598: Osteonics Solar Shoulder Humeral Bearing Head, Howmedica Osteonics Corp. (1999) Summary page 1.
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 1.
- K052472: Depuy Global Shoulder Crosslink Glenoid, DePuy Orthopaedics, Inc. (2005) Summary page 1.
- K060988: Total and Hemi Shoulder System, Dvo Extremity Solutions, LLC (2006) Summary page 1.

## Most influential descendants
- K130759: Humelock II Cementless Shoulder System (2013), 31 descendants of its own
- K150488: Humelock II Reversible Shoulder System (2015), 30 descendants of its own
- K163669: Humeris Shoulder (2017), 20 descendants of its own
- K162455: Humelock Reversed Shoulder (2017), 17 descendants of its own
- K161863: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) (2016), 13 descendants of its own

## Recalls of this device
- May 12, 2015 · Class II · Z-2363-2015: A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.

## Indications for use
For use as a Hemi or Total Shoulder Replacement: Aseptic necrosis of the humeral head Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis. Proximal humeral fractures and/or dislocation. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure. The glenoid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.

Source page: https://510kreport.com/device/K103835
Methodology: https://510kreport.com/methodology