# K220452: Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Aug 17, 2022 after 181 days
- Product code: QHE (Shoulder Arthroplasty Implantation System)
- 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: 3 generations back to K190286 (2019). 3 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212569: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, Materialise NV (2022) Summary page 5.

## Most influential descendants
- 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
- K241143: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (2024), 4 descendants of its own
- K242813: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (2024), 3 descendants of its own
- K260802: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (2026), 0 descendants of its own

## Indications for use
Hardware The Materialise Shoulder Guide and Models are 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 Shoulder Guide and Models are single use only. The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components: * Depuy Synthes' - GLOBAL® APG+ Shoulder System (K052472) - DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077, K203694) - GLOBAL® STEPTECH® APG Shoulder System (K092122) - INHANCE™ Anatomic Shoulder System (K202716) - INHANCE™ Reverse Shoulder System (K212737) * DJO's - Reverse® Shoulder Prosthesis (K051075, K111629, K092873) - Turon® Shoulder System (K080402) - AltiVate™ Anatomic Shoulder System (K162024) * Smith & Nephew's - Titan™ Total Shoulder System (K100448, K112438, K142413, K152047) - Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999) * Lima's - SMR™ Shoulder System (K100858) - SMR™ Reverse Shoulder System (K110598) - SMR™ Modular Glenoid (K113254) (K143256) - SMR™ 3-Pegs Glenoid (K130642) - SMR™ TT Metal Back Glenoid (K133349) - SMR™ 40mm Glenosphere (K142139) Stryker's - ReUnion RSA Reverse Shoulder System (K183039) - Reunion TSA Total Shoulder Arthroplasty System (K183039) 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 shoulder 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 Shoulder Guide and Models.

Source page: https://510kreport.com/device/K220452
Methodology: https://510kreport.com/methodology