510(k) · Cleared
ClearedTruMatch CMF Titanium 3D Printed Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · JEY Plate, Bone
Cleared on Jul 10, 2018 as substantially equivalent to K170272 (Materialise NV, 2017) after a 285-day review. Its family tree reaches back 2 generations to 2007. 2 later devices descend from it.
- Decided
- Jul 10, 2018
- Review
- 285 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K063790 (2007). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK063790 The Synthes Matrixmandible Plate and Screw SystemSynthes (Usa) · 2007
- 1 generation backK170272 TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV · 2017 · Recalled
- This deviceK173039 TruMatch CMF Titanium 3D Printed ImplantMaterialise NV · 2018
- Descendant · cites it directly · 0 of its ownK233874 tmCMF SolutionTechmah Cmf · 2024
- Descendant · cites it directly · 0 of its ownK232889 METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd. · 2024
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 |
|---|---|---|---|---|---|
| −2 | K063790 | The Synthes Matrixmandible Plate and Screw System | Synthes (Usa) | 2007 | — |
| −1 | K170272 | TruMatch CMF Titanium 3D Printed Implant System | Materialise NV | 2017 | 2 |
| 0 (this device) | K173039 | TruMatch CMF Titanium 3D Printed Implant | Materialise NV | 2018 | — |
| +1 | K233874 | tmCMF Solution | Techmah Cmf | 2024 | — |
| +1 | K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K170272 | TruMatch CMF Titanium 3D Printed Implant SystemSummary page 5…Implant System Bone plate and screw Trade or proprietary or model name TruMatch CMF Titanium 3D Printed Implant System 510(k) number K170272 Decision date 08/08/2017 Product code JEY (21 CFR 872.4760) Manufactur… | 2017 |
| † | K133809 | Osteofab Patient Specific Facial Device | 2014 |
| † | K063790 | The Synthes Matrixmandible Plate and Screw System | 2007 |
| † | K080331 | Synthes Craniofacial Plate and Screw System | 2008 |
| † | K083388 | Synthes Matrixorthognathis Fixation System | 2009 |
| † | K042365 | Synthes (Usa) Neuro Plate and Screw System | 2004 |
| † | K053199 | Synthes Patient Specific Cranial/Craniofacial Implant | 2005 |
What descends from it? (2)
2 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 11 years and passes through 2 companies; a new generation was cleared every 10.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K233874 (Techmah Cmf, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K170272.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 TruMatch CMF Titanium 3D Printed Implant is a patient specific implant and is 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 and chin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173039: TruMatch CMF Titanium 3D Printed Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173039
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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