# K170893: Materialise Glenoid Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Jun 19, 2017 after 84 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: 10 generations back to K905070 (1991). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K172054: Materialise Glenoid Positioning System (2017), 0 descendants of its own

## Recalls of this device
- Jul 17, 2020 · Class II · Z-2886-2020: The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.

## 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 AltiVate Anatomic Shoulder (K162024), Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and Reverse® Shoulder prosthesis (K092873) and their respective components, 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.

Source page: https://510kreport.com/device/K170893
Methodology: https://510kreport.com/methodology