# K213459: Glenoid Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Nov 23, 2022 after 392 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: 12 generations back to K911686 (1991). 67 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 73 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Tornier, Inc. (2016) Summary page 4.
- K120121: Comprehensive Reverse Shoulder-Mini Baseplate, Biomet, Inc. (2012) Summary page 4.
- K100741: Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012, Encore Medical L.P. (2010) Summary page 4.
- K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.

## Most influential descendants
- K231911: Glenoid Reconstruction System – Full Wedge Baseplate (2023), 4 descendants of its own
- K250644: MSS - Monobloc stem (2026), 1 descendant of its own
- K250338: MSS - Humeral reverse liners extension (2025), 1 descendant of its own
- K261016: MSS - Humeral reverse liners extension (2026), 0 descendants of its own
- K251737: NextAR (TM) Shoulder Platform (2025), 0 descendants of its own

## Indications for use
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), 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 stems are intended for cemented or cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation. The Reverse Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), 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 short stem is intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

Source page: https://510kreport.com/device/K213459
Methodology: https://510kreport.com/methodology