510(k) · Cleared
ClearedMaterialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · QHE Shoulder Arthroplasty Implantation System
Cleared on Mar 6, 2023 as substantially equivalent to K220452 (Materialise NV, 2022) after a 28-day review. Its family tree reaches back 4 generations to 2019.
- Decided
- Mar 6, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- QHE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K190286 (2019). No later device cites it as a predicate yet.
- Root · 4 generations backK190286 Materialise Glenoid Positioning SystemMaterialise NV · 2019
- 3 generations backK193560 Materialise Shoulder Guide and Models, Materialise SurgiCase…Materialise NV · 2020
- 2 generations backK212569 Materialise Shoulder System™, Materialise Shoulder Guide and Models…Materialise NV · 2022
- 1 generation backK220452 Materialise Shoulder SystemTM Materialise Shoulder Guide and Models…Materialise NV · 2022
- This deviceK230315 Materialise Shoulder System™ Materialise Shoulder Guide and Models…Materialise NV · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K190286 | Materialise Glenoid Positioning System | Materialise NV | 2019 | — |
| −3 | K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner… | Materialise NV | 2020 | — |
| −2 | K212569 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase… | Materialise NV | 2022 | — |
| −1 | K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase… | Materialise NV | 2022 | — |
| 0 (this device) | K230315 | Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase… | Materialise NV | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QHE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QHE device
- #1 K242813 Materialise Shoulder System™, Materialise…score 19.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder…Summary page 6…aterialise Shoulder Guide and Models SurgiCase Shoulder Planner 510(k) number K220452 Decision date August 17, 2022 QHE (… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 8 months on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K220452.
How does its category compare?
All QHE devicesQHE Shoulder Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QHE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QHE
181in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QHE
No recall names QHE since 2007.
Adverse event reports per year · QHE
1in 2025
MAUDE reports naming product code QHE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 3 | 88 | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 3 | 149 | 0 | 0 |
| 2023 | 6 | 103 | 0 | 0 |
| 2024 | 4 | 97 | 0 | 5 |
| 2025 | 3 | 181 | 0 | 1 |
| 2026 | 4 | 59 | 0 | — |
What is it indicated for?
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…
Read the full statement (307 words)
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)¹
- INHANCE™ Reverse Shoulder System (K212737)
• DJO’s
- Reverse® Shoulder Prosthesis (K051075, K111629, K092873)
- Turon® Shoulder System (K080402)
- AltiVate™ Anatomic Shoulder System (K162024)
• Smith+Nephew’s²
- 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)
- SMR™ TT Augmented 360 Baseplate (K220792)
- SMR™ TT Hybrid Glenoid (K220792)
• 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230315 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230315: Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230315
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026