510(k) · Cleared
ClearedtmCMF Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techmah Cmf · JEY Plate, Bone
Cleared on Jul 11, 2024 as substantially equivalent to K231520 (Techmah Cmf, 2023) and 2 other predicates after a 217-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Jul 11, 2024
- Review
- 217 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K924630 (1993). 17 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 backK192282 MedCAD® AccuPlan® SystemMedcad · 2020
- 1 generation backK231520 tmCMF SolutionTechmah Cmf · 2023
- This deviceK233874 tmCMF SolutionTechmah Cmf · 2024
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 | K192282 | MedCAD® AccuPlan® System | Medcad | 2020 | — |
| −1 | K231520 | tmCMF Solution | Techmah Cmf | 2023 | — |
| 0 (this device) | K233874 | tmCMF Solution | Techmah Cmf | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K231520 | tmCMF SolutionSummary page 5…21 CFR §872.4120 Product Code: JEY Subsequent Product Code: DZJ, LLZ III. LEGALLY MARKETED PREDICATE DEVICES Predicate Number: K231520 Predicate Trade Name: tmCMF Solution Product Code: DZJ & LLZ Use: Primary… | 2023 |
| * | K173039 | TruMatch CMF Titanium 3D Printed ImplantSummary page 6…Page 1 of 21 TechMah CMF LLC K233874/S001 tmCMF Solution 510(k) Submission Predicate Number: K173039 Predicate Trade Name: TruMatch CMF Titanium 3D Printed Implant Product Code: JEY Use:… | 2018 |
| * | K170272 | TruMatch CMF Titanium 3D Printed Implant SystemSummary page 6…cate Trade Name: TruMatch CMF Titanium 3D Printed Implant Product Code: JEY Use: Secondary Predicate Predicate Number: K170272 Predicate Trade Name: TruMatch CMF Titanium 3D Printed Implant System Product Code: JEY Use:… | 2017 |
| † | K063790 | The Synthes Matrixmandible Plate and Screw System | 2007 |
| † | K210731 | KLS Martin Individual Patient Solutions | 2022 |
| † | K213684 | SurgiCase Viewer | 2022 |
| † | K080331 | Synthes Craniofacial Plate and Screw System | 2008 |
| † | K050608 | Synthes Carniofacial Plate and Screw System | 2005 |
| † | K083388 | Synthes Matrixorthognathis Fixation System | 2009 |
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 31 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 17 ancestors have a recall of any class.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
The tmCMF Solution 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 tmCMF Solution, and the result is an output data file that may then be provided as digital models or used as input to a manufacturing portion of the system that produces physical outputs, including anatomical models, surgical guides…
Read the full statement (160 words)
The tmCMF Solution 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 tmCMF Solution, and the result is an output data file that may then be provided as digital models or used as input to a manufacturing portion of the system that produces physical outputs, including anatomical models, surgical guides, dental splints, and implants for use in maxillofacial, midface, and mandibular surgery. Implants are intended for bone fixation and reconstruction, restoration of bone defects, and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface, mandible, and chin in adolescents (greater than 12 to 21 years of age) and adults. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating virtual surgical treatment options.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233874 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233874: tmCMF Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233874
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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