510(k) · Cleared
Recalled · Class II · 2020Materialise 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 Apr 26, 2016 as substantially equivalent to K131559 (Materialise NV, 2013) after a 131-day review. Its family tree reaches back 9 generations to 1991. 2 later devices descend from it. It has been recalled once.
- Decided
- Apr 26, 2016
- Review
- 131 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K905070 (1991). 31 ancestors in all, the oldest K861692 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 5 generations between
- 3 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 2 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 1 generation backK131559 Match Point System (TM), Surgicase Connect, Match Point System (TM)…Materialise NV · 2013
- This deviceK153602 Materialise Glenoid Positioning SystemMaterialise NV · 2016
- Descendant · cites it directly · 1 of its ownK170893 Materialise Glenoid Positioning SystemMaterialise NV · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK172054 Materialise Glenoid Positioning SystemMaterialise NV · 2017
Show all 9 generations
- Root · 9 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 8 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 7 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 6 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 5 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 4 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 3 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 2 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 1 generation backK131559 Match Point System (TM), Surgicase Connect, Match Point System (TM)…Materialise NV · 2013
- This deviceK153602 Materialise Glenoid Positioning SystemMaterialise NV · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −8 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −7 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −6 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −5 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −4 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −3 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −2 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −1 | K131559 | Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides | Materialise NV | 2013 | — |
| 0 (this device) | K153602 | Materialise Glenoid Positioning System | Materialise NV | 2016 | — |
| +1 | K170893 | Materialise Glenoid Positioning System | Materialise NV | 2017 | 1 |
| +1 | K172054 | Materialise Glenoid Positioning System | Materialise NV | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131559 | Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesSummary page 5…Trade or proprietary or model name SurgiCase Connect 510(k) number K131559 Decision date September 27th, 2013 Classification product code… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2020 | Class II | Z-2886-2020 | Software Design Change | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 7 of the 31 ancestors have a recall of any class.
- Of its descendants, K170893 (Materialise NV, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K131559.
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. 2016, 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?
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…
Read the full statement (139 words)
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 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.
The Materialise Glenoid Positioning System guide is single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153602: 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/K153602
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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