# K172054: Materialise Glenoid Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Nov 3, 2017 after 120 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
Longest line of descent: 11 generations back to K905070 (1991). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170893: Materialise Glenoid Positioning System, Materialise NV (2017) Summary page 5.
- K153602: Materialise Glenoid Positioning System, Materialise NV (2016) Summary page 7.

## Indications for use
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 ReUnion RSA Reverse Shoulder System (K130895) and its respective components, with DJO’s following total and reverse shoulder implant systems and their respective compatible components: the Reverse® Shoulder Prosthesis (K051075, K111629, K092873, K112069), the Turon® Shoulder System (K080402, K123982), and the AltiVate™ Anatomic Shoulder System (K162024), and Lima’s 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 their respective components and Depuy Synthes” GLOBAL® APG+ Shoulder System (K052472), the DELTA XTEND™ Reverse Shoulder System (K120174, K062250) and the GLOBAL® STEPTECH® APG Shoulder System (K092122) and their respective components. The Materialise Glenoid Positioning System guide is single use only. Surgicase 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 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.

Source page: https://510kreport.com/device/K172054
Methodology: https://510kreport.com/methodology