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. · DZJ Driver, Wire, And Bone Drill, Manual
Cleared on Sep 13, 2018 as substantially equivalent to K120956 (Medical Modeling, Inc., 2012) after a 126-day review. Its family tree reaches back 5 generations to 1993. 12 later devices descend from it.
- Decided
- Sep 13, 2018
- Review
- 126 days
- Class
- Class II
- Product code
- DZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924630 (1993). 10 ancestors in all, the oldest K924810 (1993). 12 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 4 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 3 generations backK033849 Simplant SystemMaterialise NV · 2004
- 2 generations backK060950 3MATICMaterialise NV · 2006
- 1 generation backK120956 VSP SystemMedical Modeling, Inc. · 2012
- This deviceK181241 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2018
- Descendant · cites it directly · 7 of its ownK182789 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2019
- Descendant · 2 generations on · 2 of its ownK192979 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2020
- Descendant · 2 generations on · 1 of its ownK243637 Materialise Personalized Guides and Models for Craniomaxillofacial…Materialise NV · 2025
- Descendant · 3 generations on · 1 of its ownK211614 CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK201353 CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2019 · cites it directly7descendants
- K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2020 · 2 generations on2descendants
- K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV · 2025 · 2 generations on1descendant
- K211614CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc. · 2022 · 3 generations on1descendant
- K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc. · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −4 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −3 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −2 | K060950 | 3MATIC | Materialise NV | 2006 | — |
| −1 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
| 0 (this device) | 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 | — |
| +2 | K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2020 | — |
| +2 | K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | 2025 | — |
| +3 | K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | 2022 | — |
| +1 | K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | 2021 | — |
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 |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 DZJ? 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 DZJ device
- #1 K243637 Materialise Personalized Guides and Models for…score 13.7 · 7 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 |
|---|---|---|---|
| * | K120956 | VSP SystemSummary page 4…stem, Image Processing, Radiological (21 CFR 892.2050 Regulatory Class: II Product Code: DZJ, LLZ Predicate Device: VSP System (K120956) - Primary Reference Devices: KLS Martin Individual Patient Solutions (K163579) KLS Mini Osteosynthesi… | 2012 |
| † | K163579 | KLS Martin Individual Patient Solutions | 2017 |
| † | K943347 | KLS Mini Osteosynthesis System | 1994 |
| † | K971297 | Centre-Drive Drill-Free Screw | 1997 |
What descends from it? (12)
See all 123 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 25 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K182789 (KLS-Martin L.P., 2019) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K120956.
How does its category compare?
All DZJ devicesDZJ Driver, Wire, And Bone Drill, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZJ
142in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZJ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZJ
14in 2025
MAUDE reports naming product code DZJ, 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 | 10 |
| 2009 | 0 | — | 0 | 142 |
| 2010 | 0 | — | 0 | 517 |
| 2011 | 0 | — | 5 | 578 |
| 2012 | 1 | — | 0 | 621 |
| 2013 | 0 | — | 1 | 809 |
| 2014 | 1 | — | 0 | 539 |
| 2015 | 2 | — | 0 | 18 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 2 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 4 | 379 | 0 | 17 |
| 2021 | 3 | 403 | 0 | 22 |
| 2022 | 3 | 179 | 0 | 23 |
| 2023 | 3 | 142 | 0 | 22 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 2 | — | 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 as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, guides, splints, and case reports for use in maxillofacial 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/K181241 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181241: 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/K181241
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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