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 Aug 31, 2020 as substantially equivalent to K182889 (KLS-Martin L.P., 2019) after a 132-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Aug 31, 2020
- Review
- 132 days
- Class
- Class II
- Product code
- PPT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K924630 (1993). 12 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 5 generations backK033849 Simplant SystemMaterialise NV · 2004
- 4 generations backK060950 3MATICMaterialise NV · 2006
- 3 generations backK120956 VSP SystemMedical Modeling, Inc. · 2012
- 2 generations backK181241 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2018
- 1 generation backK182889 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2019
- This deviceK201052 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −6 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −5 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −4 | K060950 | 3MATIC | Materialise NV | 2006 | — |
| −3 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
| −2 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2018 | — |
| −1 | K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2019 | — |
| 0 (this device) | 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 |
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 12.8 · 8 generations · no Class I recall
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 |
|---|---|---|---|
| * | K182889 | KLS Martin Individual Patient Solutions (IPS) Planning SystemSummary page 4…lass: II Product Code: PPT Predicate Device: KLS Martin Individual Patient Solutions (IPS) Planning System (K182889) Reference Devices: KLS Martin Individual Patient Solutions (IPS) Planning System (K182789)… | 2019 |
| † | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | 2019 |
| † | K190229 | Stryker PEEK Customized Cranial Implant Kit | 2019 |
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 27 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
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. 2020, 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 (145 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 and cutting 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. Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider’s judgment and analysis of the patient’s condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201052 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201052: 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 3, 2026. https://510kreport.com/device/K201052
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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