510(k) · Cleared
ClearedKLS Martin Individual Patient Solutions (IPS) Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · PPT Cranial Surgical Planning And Instrument Guides
Cleared on Jul 26, 2019 as substantially equivalent to K181241 (KLS-Martin L.P., 2018) after a 284-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Jul 26, 2019
- Review
- 284 days
- Class
- Class II
- Product code
- PPT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924630 (1993). 11 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK060950 3MATICMaterialise NV · 2006
- 2 generations backK120956 VSP SystemMedical Modeling, Inc. · 2012
- 1 generation backK181241 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2018
- This deviceK182889 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2019
- Descendant · cites it directly · 0 of its ownK201052 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K060950 | 3MATIC | Materialise NV | 2006 | — |
| −2 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
| −1 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2018 | — |
| 0 (this device) | K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2019 | — |
| +1 | K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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 PPT? 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 PPT device
- #1 K253308 Materialise Personalized Guides and Models for…score 12.7 · 8 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning SystemSummary page 4…y Class: II, 21 CFR 882.4310 Product Code: PPT Predicate Devices: KLS Martin Individual Patient Solutions (IPS) Planning System (K181241) – Primary Reference Devices: KLS Martin Individual Patient Solutions (K163579) KLS Martin Individual… | 2018 |
| † | K163579 | KLS Martin Individual Patient Solutions | 2017 |
| † | K180962 | KLS Martin Individual Patient Solutions | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System | 2020 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K201052 (KLS-Martin L.P., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K181241.
How does its category compare?
All PPT devicesPPT Cranial Surgical Planning And Instrument Guides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PPT
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PPT
Too few PPT 510(k)s in any year since 2007 to give a median.
Recalls per year · PPT
No recall names PPT since 2007.
Adverse event reports per year · PPT
No MAUDE report names PPT since 2007.
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 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a computerized tomography (CT) medical scan. The input data file is processed by the IPS Planning System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical…
Read the full statement (114 words)
The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a computerized tomography (CT) medical scan. The input data file is processed by the IPS Planning System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, guides and case reports for use in the marking of cranial bone in cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182889: KLS Martin Individual Patient Solutions (IPS) Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182889
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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