# K212569: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Jan 12, 2022 after 149 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: 2 generations back to K190286 (2019). 2 ancestors in all.
11 later devices descend from it; 2 cite 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)
- K193560: Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner, Materialise NV (2020) Summary page 6.

## Most influential descendants
- 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
- 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

## 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' o GLOBAL@ APG+ Shoulder System (K052472), " DELTA XTENDTM Reverse Shoulder System (K120174, K062250, K183077, K203694) o GLOBAL@ STEPTECH@ APG Shoulder System (K092122) o Ignite Anatomic Shoulder System (K202716) (rebranded to INHANCETm Anatomic Shoulder System)' * DJO's o Reverse@ Shoulder Prosthesis (K051075, K 11629, K092873), o Turon@ Shoulder System (K080402) o AltiVateTm Anatomic Shoulder System (K162024) * Smith & Nephew's (Integra's) 2 o TitanTm Total Shoulder System (K100448, K112438, Kl42413, K152047) o TitanTm Reverse Shoulder System (K130050, K161189, K1 73717, K181999) * Lima's o SMRTM Shoulder System (KI00858), o SMRTm Reverse Shoulder System (KI10598), o SMRTM Modular Glenoid (KI13254) (K143256), o SMRTm 3-Pegs Glenoid (K130642), o SMRTM TT Metal Back Glenoid (K133349), o SMRTM 40mm Glenosphere (K142139). * Stryker's o ReUnion RSA Reverse Shoulder System (Kl83039) o Reunion TSA Total Shoulder Arthroplasty System (KI83039). 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 ofa 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/K212569
Methodology: https://510kreport.com/methodology