510(k) · Cleared
ClearedModus Titanium Osteosynthesis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medartis, Inc. · JEY Plate, Bone
Cleared on May 5, 2005 as substantially equivalent to K946165 (Elekta Instruments, Inc., 1995) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- May 5, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950045 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK950045 KLS-Martin Mandibular Fracture/Reconstruction SystemKarl Leibinger GmbH U. Co. KG · 1995
- 1 generation backK992683 Modus 2.5 Mandibular Trauma SetMedartis AG · 1999
- This deviceK050934 Modus Titanium Osteosynthesis SystemMedartis, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK071612 Modus Trilock 2.0/2.3/2.5Medartis AG · 2007
Most influential descendants
Showing 1 of 1 · See all- K071612Modus Trilock 2.0/2.3/2.5Medartis AG · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950045 | KLS-Martin Mandibular Fracture/Reconstruction System | Karl Leibinger GmbH U. Co. KG | 1995 | — |
| −1 | K992683 | Modus 2.5 Mandibular Trauma Set | Medartis AG | 1999 | — |
| 0 (this device) | K050934 | Modus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | — |
| +1 | K071612 | Modus Trilock 2.0/2.3/2.5 | Medartis AG | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K946165 | CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) SystemSummary page 1…Medartis, Inc. has acquired the rights to the Elekta Instruments, Inc. CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation System, cleared by FDA on May 23, 1995 under K946165, and has marketed it as the MODUS®Titanium Osteosynthesis System. The MODUS System was expanded with the addition of the MODUS* 2… | 1995 |
| * | K992683 | Modus 2.5 Mandibular Trauma SetSummary page 2….5 Mandibular Trauma Set, cleared by FDA 510(k) Summary - Modifications to the MODUS® Titanium Osteosynthesis System - Page 2 on November 24, 1999 under K992683. The MODUS System has now been modified by the addition of new shapes, which are the subject of this Special 510(k). PACKAGING/L… | 1999 |
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 |
|---|---|---|---|
| K071612 | Modus Trilock 2.0/2.3/2.5 | 2007 | 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 10 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K071612 (Medartis AG, 2007) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K946165.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MODUS ® Titanium Osteosynthesis System is intended for osteotomies and fractures involving any part of the craniofacial skeleton and requiring positional and functional stability. Indications include fixation in the nasoethmoidal, intraorbital, and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and craniofacial areas; tumor surgery for defect bridging; reconstruction of bony structures by means of mesh materials; coverings for burr holes in the skull; trauma of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050934 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050934: Modus Titanium Osteosynthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050934
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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