510(k) · Cleared
ClearedMax-Face Maxillofacial Osteosynthesis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Technology USA, Inc. · JEY Plate, Bone
Cleared on Oct 29, 2008 as substantially equivalent to K944565 (KLS-Martin L.P., 1994) and 1 other predicate after a 341-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Oct 29, 2008
- Review
- 341 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944565 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK944565 KLS-Martin Micro Osteosythesis System (1.5MM)KLS-Martin L.P. · 1994
- This deviceK073307 Max-Face Maxillofacial Osteosynthesis SystemBio-Technology USA, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM) | KLS-Martin L.P. | 1994 | — |
| 0 (this device) | K073307 | Max-Face Maxillofacial Osteosynthesis System | Bio-Technology USA, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (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 |
|---|---|---|---|
| * | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM)Summary page 1…4760 Panel: Dental Product Code: JEY Predicate Device Information: This device is substantially equivalent to the KLS Martin Micro-Osteosynthesis System, marketed under K944565, and the Synthes Craniofacial Plates, marketed under K021642. Device Description: The MaxFace Maxillofacial Ostheosynthesis Syst… | 1994 |
| * | K021642 | Synthes Craniofacial PlatesSummary page 1…ation: This device is substantially equivalent to the KLS Martin Micro-Osteosynthesis System, marketed under K944565, and the Synthes Craniofacial Plates, marketed under K021642. Device Description: The MaxFace Maxillofacial Ostheosynthesis System is composed of plates and screws, which are available in f… | 2002 |
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?
- None of the 2 ancestors has a recall.
- 14 other devices also cite its predicate K944565.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 MaxFace Maxillofacial Ostheosynthesis System is indicated for trauma fixation of the superior, middle and inferior segments of the facial skeleton, for ostheosynthesis of corrective osteotomies in congenital deformities treatment (acquired or in development) and for the fixation of grafts in reconstructive surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073307: Max-Face Maxillofacial Osteosynthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073307
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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