# K190286: Materialise Glenoid Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Jul 8, 2019 after 147 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K172054: Materialise Glenoid Positioning System, Materialise NV (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K193560: Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner (2020), 12 descendants of its own
- K212569: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (2022), 11 descendants of its own
- K220452: Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner (2022), 8 descendants of its own
- K231112: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (2023), 6 descendants of its own
- K233408: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (2023), 5 descendants of its own

## Indications for use
Hardware The Materialise Glenoid Positioning System is intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Materialise Glenoid Positioning System can be used in conjunction with Stryker’s following total and reverse shoulder implants systems and their respective compatible components: ReUnion RSA Reverse Shoulder System (K183039) and Reunion TSA Total Shoulder Arthroplasty System (K183039), with DJO’s following total and reverse shoulder implant systems and their respective compatible components: Reverse® Shoulder Prosthesis (K051075, K111629, K092873), Turon® Shoulder System (K080402) and AltiVate™ Anatomic Shoulder System (K162024), with Lima’s following total and reverse shoulder implant systems and their respective compatible components: SMR Shoulder System (K100858), SMR Reverse Shoulder System (K110598), SMR Modular Glenoid (K113254), SMR 3-Pegs Glenoid (K130642), SMR TT Metal Back Glenoid (K133349), SMR 40mm Glenosphere (K142139) and SMR Modular Glenoid (K143256), and with Depuy Synthes’ following total and reverse shoulder implant systems and their respective compatible components: GLOBAL® APG+ Shoulder System (K052472), DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077) and GLOBAL® STEPTECH® APG Shoulder System (K092122). The Materialise Glenoid Positioning System Guide and Models are single use only. Software SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of glenoid components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Glenoid Positioning Guide and Models.

Source page: https://510kreport.com/device/K190286
Methodology: https://510kreport.com/methodology