510(k) · Cleared
Recalled · Class II · 2020TruMatch CMF Titanium 3D Printed Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · JEY Plate, Bone
Cleared on Aug 8, 2017 as substantially equivalent to K083388 (Synthes (Usa), 2009) and 2 other predicates after a 190-day review. Its family tree reaches back 1 generation to 2007. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 8, 2017
- Review
- 190 days
- Class
- Class II
- Product code
- JEY
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K063790 (2007). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK063790 The Synthes Matrixmandible Plate and Screw SystemSynthes (Usa) · 2007
- This deviceK170272 TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV · 2017
- Descendant · cites it directly · 2 of its ownK173039 TruMatch CMF Titanium 3D Printed ImplantMaterialise NV · 2018
- Descendant · cites it directly · 1 of its ownK182305 Stryker Facial iD Plating SystemStryker · 2019
- Descendant · cites it directly · 0 of its ownK233874 tmCMF SolutionTechmah Cmf · 2024
- Descendant · 2 generations on · 0 of its ownK232889 METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK193143 Stryker Facial iD Plating SystemStryker · 2020
Most influential descendants
Showing 5 of 5 · See all- K173039TruMatch CMF Titanium 3D Printed ImplantMaterialise NV · 2018 · cites it directly2descendants
- K182305Stryker Facial iD Plating SystemStryker · 2019 · cites it directly1descendant
- K233874tmCMF SolutionTechmah Cmf · 2024 · cites it directly0descendants
- K232889METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd. · 2024 · 2 generations on0descendants
- K193143Stryker Facial iD Plating SystemStryker · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063790 | The Synthes Matrixmandible Plate and Screw System | Synthes (Usa) | 2007 | — |
| 0 (this device) | K170272 | TruMatch CMF Titanium 3D Printed Implant System | Materialise NV | 2017 | — |
| +1 | K173039 | TruMatch CMF Titanium 3D Printed Implant | Materialise NV | 2018 | — |
| +1 | K182305 | Stryker Facial iD Plating System | Stryker | 2019 | — |
| +1 | K233874 | tmCMF Solution | Techmah Cmf | 2024 | — |
| +2 | K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | 2024 | — |
| +2 | K193143 | Stryker Facial iD Plating System | Stryker | 2020 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K083388 | Synthes Matrixorthognathis Fixation SystemSummary page 5…Plating System Bone plate and screw Trade or proprietary or model name Synthes MatrixORTHOGNATHIC Plating System 510(k) number K083388 Decision date 03/12/2009 Product code JEY (21 CFR 872.4760) Manu… | 2009 |
| * | K063790 | The Synthes Matrixmandible Plate and Screw SystemSummary page 6…and Screw System Bone plate and screw Trade or proprietary or model name Synthes MatrixMANDIBLE Plate and Screw System 510(k) number K063790 Decision date 04/16/2007 Product code JEY (21 CFR 872.4760) Manufactur… | 2007 |
| * | K080331 | Synthes Craniofacial Plate and Screw SystemSummary page 6…e and Screw System Bone plate and screw Trade or proprietary or model name Synthes Craniofacial Plate and Screw System 510(k) number K080331 Decision date 04/30/2008 Product code JEY (21 CFR 872.4760) Manufactur… | 2008 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2020 | Class II | Z-1485-2020 | Employee error | Custom surgical kits contain a plate different than indicated by the package labeling. |
| Feb 3, 2020 | Class II | Z-1484-2020 | Employee error | Custom surgical kits contain a plate different than indicated by the package labeling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 System is intended for bone repositioning, fixation and reconstruction of the maxillofacial skeleton, midface, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults.
Specific indications for use:
• Orthognathic surgery.
• Reconstructive mandible and maxillofacial surgery.
• Mandible and maxillofacial trauma surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170272: TruMatch CMF Titanium 3D Printed Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170272
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