510(k) · Cleared
ClearedMaterialise Glenoid Positioning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jul 8, 2019 after a 147-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 13 later devices descend from it.
- Decided
- Jul 8, 2019
- Review
- 147 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
13 later devices descend from it, 1 citing it directly.
- This deviceK190286 Materialise Glenoid Positioning SystemMaterialise NV · 2019
- Descendant · cites it directly · 12 of its ownK193560 Materialise Shoulder Guide and Models, Materialise SurgiCase…Materialise NV · 2020
- Descendant · 2 generations on · 11 of its ownK212569 Materialise Shoulder System™, Materialise Shoulder Guide and Models…Materialise NV · 2022
- Descendant · 3 generations on · 8 of its ownK220452 Materialise Shoulder SystemTM Materialise Shoulder Guide and Models…Materialise NV · 2022
- Descendant · 4 generations on · 6 of its ownK231112 Materialise Shoulder System™, Materialise Shoulder Guide and Models…Materialise NV · 2023
- Descendant · 5 generations on · 5 of its ownK233408 Materialise Shoulder System™, Materialise Shoulder Guide and Models…Materialise NV · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner…Materialise NV · 2020 · cites it directly12descendants
- K212569Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV · 2022 · 2 generations on11descendants
- K220452Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder…Materialise NV · 2022 · 3 generations on8descendants
- K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV · 2023 · 4 generations on6descendants
- K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV · 2023 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190286 | Materialise Glenoid Positioning System | Materialise NV | 2019 | — |
| +1 | 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 | — |
| +3 | K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase… | Materialise NV | 2022 | — |
| +4 | K231112 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase… | Materialise NV | 2023 | — |
| +5 | K233408 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase… | Materialise NV | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
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 KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K172054 | FDA’s K172054 is Materialise Glenoid Positioning System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2017 |
| † | K170893 | Materialise Glenoid Positioning System | 2017 |
| † | K153602 | Materialise Glenoid Positioning System | 2016 |
| † | K131559 | Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides | 2013 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner… | 2020 | 12 |
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?
- Of its descendants, K193560 (Materialise NV, 2020) has gone furthest, with 12 descendants of its own.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Hardware 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 following total and reverse shoulder implants…
Read the full statement (290 words)
Hardware
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 following total and reverse shoulder implants systems and their respective compatible components: ReUnion RSA Reverse Shoulder System (K183039) and Reunion TSA Total Shoulder Arthroplasty System (K183039), with DJO’s following total and reverse shoulder implant systems and their respective compatible components: Reverse® Shoulder Prosthesis (K051075, K111629, K092873), Turon® Shoulder System (K080402) and AltiVate™ Anatomic Shoulder System (K162024), with Lima’s following total and reverse shoulder implant systems and their respective compatible components: 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 with Depuy Synthes’ following total and reverse shoulder implant systems and their respective compatible components: GLOBAL® APG+ Shoulder System (K052472), DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077) and GLOBAL® STEPTECH® APG Shoulder System (K092122).
The Materialise Glenoid Positioning System Guide and Models are single use only.
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 glenoid 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 Glenoid Positioning Guide and Models.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190286: Materialise Glenoid Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190286
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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