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. · PBF Orthopaedic Surgical Planning And Instrument Guides
Cleared on Mar 11, 2020 as substantially equivalent to K182789 (KLS-Martin L.P., 2019) after a 139-day review. Its family tree reaches back 7 generations to 1993. 2 later devices descend from it.
- Decided
- Mar 11, 2020
- Review
- 139 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K924630 (1993). 12 ancestors in all, the oldest K924810 (1993). 2 later devices descend from it, 1 citing it directly.
- 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 backK182789 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2019
- This deviceK192979 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2020
- Descendant · cites it directly · 1 of its ownK211614 CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK223421 MedCAD AccuPlan Orthopedics SystemMedcad · 2023
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 |
|---|---|---|---|---|---|
| −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 | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2019 | — |
| 0 (this device) | K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2020 | — |
| +1 | K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | 2022 | — |
| +2 | K223421 | MedCAD AccuPlan Orthopedics System | Medcad | 2023 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 PBF? 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 PBF device
- #1 K241811 MedCAD® AccuStride™ Systemscore 17.1 · 8 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 |
|---|---|---|---|
| * | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning SystemSummary page 4…II Product Codes: PBF, LLZ Regulation Number: 21 CFR 888.3030, 21 CFR 892.2050 Primary Predicate: KLS Martin IPS Planning System (K182789) Reference Devices: KLS Martin IPS Planning System (K181241) KLS Martin Individual Patie… | 2019 |
| † | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | 2018 |
| † | K163579 | KLS Martin Individual Patient Solutions | 2017 |
| † | K153482 | KLS Martin Thoracic Plating System | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | 2022 | 1 |
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.
- Of its descendants, K211614 (Centermed, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K182789.
How does its category compare?
All PBF devicesPBF Orthopaedic 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 · PBF
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBF
227in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBF
No recall names PBF since 2007.
Adverse event reports per year · PBF
62in 2025
MAUDE reports naming product code PBF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 12 |
| 2022 | 3 | 435 | 0 | 53 |
| 2023 | 5 | 314 | 0 | 45 |
| 2024 | 3 | 62 | 0 | 34 |
| 2025 | 8 | 227 | 0 | 62 |
| 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 medical scanner such as a CT based system. 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 in an additive manufacturing portion of the system that produces physical outputs…
Read the full statement (113 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 medical scanner such as a CT based system. 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 in an additive manufacturing portion of the system that produces physical outputs including anatomical models, guides, and case reports for use in thoracic (excluding spine) and reconstructive surgeries. 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/K192979 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192979: 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 5, 2026. https://510kreport.com/device/K192979
Report an extraction error
Are you the manufacturer?
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