510(k) · Cleared
ClearedOsteoPlan System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed, LLC · DZJ Driver, Wire, And Bone Drill, Manual
Cleared on Feb 11, 2022 as substantially equivalent to K133907 (Medical Modeling, Inc., 2014) and 1 other predicate after a 179-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Feb 11, 2022
- Review
- 179 days
- Class
- Class II
- Product code
- DZJ
- Recalls
- None
- Predicates
- 2
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 backK133907 VSP SystemMedical Modeling, Inc. · 2014 · Recalled
- This deviceK212570 OsteoPlan SystemOsteomed, LLC · 2022
- Descendant · cites it directly · 0 of its ownK223427 Mimics Enlight CMFMaterialise NV · 2024
Most influential descendants
Showing 1 of 1 · See all- K223427Mimics Enlight CMFMaterialise NV · 2024 · 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 | K133907 | VSP System | Medical Modeling, Inc. | 2014 | 1 |
| 0 (this device) | K212570 | OsteoPlan System | Osteomed, LLC | 2022 | — |
| +1 | K223427 | Mimics Enlight CMF | Materialise NV | 2024 | — |
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 |
|---|---|---|
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K133907 | VSP SystemSummary page 4…Class II, 21 CFR 872.4120 Product Code: DZJ, LLZ III. PREDICATE DEVICES Predicate Device: VSP® System, Medical Modeling, Inc (K133907, K120956) Reference Device: Surgicase Guides, Materialise (K103136) IV. DEVICE DESCRIPTION OsteoMed uses comput… | 2014 |
| * | K120956 | VSP SystemSummary page 4…Class II, 21 CFR 872.4120 Product Code: DZJ, LLZ III. PREDICATE DEVICES Predicate Device: VSP® System, Medical Modeling, Inc (K133907, K120956) Reference Device: Surgicase Guides, Materialise (K103136) IV. DEVICE DESCRIPTION OsteoMed uses computer aided… | 2012 |
| † | K103136 | Surgicase CMF, Surgicase Connect, Surgicase Guide | 2011 |
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 |
|---|---|---|---|
| K223427 | Mimics Enlight CMF | 2024 | 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 29 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K223427 (Materialise NV, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K133907.
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. 2022, 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 OsteoPlanm 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 OsteoPlanm System and the result is an output data file that may then be provided as digital models or used as input to the additive manufacturing portion of the system that produces physical outputs including anatomic models and splints for use in maxillofacial surgery. The OsteoPlan 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/K212570 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212570: OsteoPlan System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212570
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