510(k) · Cleared
ClearedMatch Point System (TM), Surgicase Connect, Match Point System (TM) Guides
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 Sep 27, 2013 as substantially equivalent to K111863 (Materialise NV, 2012) and 4 other predicates after a 120-day review. Its family tree reaches back 8 generations to 1991. 35 later devices descend from it.
- Decided
- Sep 27, 2013
- Review
- 120 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K905070 (1991). 30 ancestors in all, the oldest K861692 (1986). 35 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 7 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 6 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 5 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 4 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 3 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 2 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 1 generation backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- This deviceK131559 Match Point System (TM), Surgicase Connect, Match Point System (TM)…Materialise NV · 2013
- Descendant · cites it directly · 31 of its ownK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- Descendant · 2 generations on · 25 of its ownK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- Descendant · 3 generations on · 23 of its ownK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- Descendant · 4 generations on · 18 of its ownK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- Descendant · 5 generations on · 8 of its ownK213546 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015 · cites it directly31descendants
- K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016 · 2 generations on25descendants
- K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017 · 3 generations on23descendants
- K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021 · 4 generations on18descendants
- K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −7 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −6 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −5 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −4 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −3 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −2 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −1 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| 0 (this device) | K131559 | Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides | Materialise NV | 2013 | — |
| +1 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| +2 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| +3 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| +4 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | — |
| +5 | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2022 | 1 |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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? (5)
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 |
|---|---|---|---|
| * | K111863 | Signature Planner,Signature GuidesSummary page 1…Signature Personalized Patient Care System - Acetabular name Guide System 510(k) number K111863 Decision date 06/15/2012 Product codes JO!, KWY, KWZ, LPH, LZO, MAY,… | 2012 |
| * | K051075 | Encore Reverse Shoulder ProsthesisSummary page 2…Decision Product Trade or proprietary Manufacturer number date code or model name K051075 05/27/2005 KWS Encore Shoulder Encore Medical, L.P. _______… | 2005 |
| * | K080402 | Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model…Summary page 3…oulder implant systems and their respective compatible components: Encore Shoulder System (K051075), Turon'" to RSP Conversion Shell (K111629), Turon' M Shoulder System (K080402) and. Reverse® Shoulder prosthesis (K(092873). The Match Point System' guides are intended for single use only. Summary of tech… | 2008 |
| * | K111629 | Turon RSP Socket Shell-Neutral Model 508-02-000, Turon RSP Socket Shell-Offset Model…Summary page 3…h the following total and reverse shoulder implant systems and their respective compatible components: Encore Shoulder System (K051075), Turon'" to RSP Conversion Shell (K111629), Turon' M Shoulder System (K080402) and. Reverse® Shoulder prosthesis (K(092873). The Match Point System' guides are intended f… | 2011 |
| * | K092873 | Reverse Shoulder ProsthesisSummary page 2…KWS Turon TM to RSP Encore Medical, L.P. __________ ________Conversion Shell K(092873 10/27/2009 KWS Reverse0 Shoulder OJO Surgical ___________… | 2009 |
What descends from it? (35)
See all 352 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)
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 22 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 7 of the 30 ancestors have a recall of any class.
- Of its descendants, K143374 (Tornier S.A.S., 2015) has gone furthest, with 31 descendants of its own.
- 4 other devices also cite its predicate K111863.
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. 2013, 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 Match Point System'" is intended to be used as a surgical instrument to assist in the intraoperatlve positioning of glenoid components used with total and reverse shoulder arthroplasty procedures which utilize anatomic landmarks that are identifiable on preoperative aT or MR[ medical images.
The Match Point System" can be used with the following total and reverse shoulder implant systems and their respective compatible components: Encore Shoulder System (1(051075), Turon'" to ASP Conversion Shell (K111629), Turon' Shoulder System (K080402) and Reverse* Shoulder prosthesis (K(092873).
The Match Point System'" Guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131559: Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131559
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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