510(k) Report

510(k) · Cleared

Cleared

Modus 2.5 Mandibular Reconstruction Set

K992682510(k) TraditionalCleared Nov 24, 1999106-day reviewClass II21 CFR 872.4760

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medartis AG · JEY Plate, Bone

Cleared on Nov 24, 1999 as substantially equivalent to K946165 (Elekta Instruments, Inc., 1995) and 2 other predicates after a 106-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.

Decided
Nov 24, 1999
Review
106 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K946165 (1995). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 2 other ancestors2002: 1 descendant cleared2007: 1 descendant clearedK946165 · CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System · Elekta Instruments, Inc. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants K946165 · CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System · Elekta Instruments, Inc. · 19950
  1. Root · 1 generation backK946165 CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation…Elekta Instruments, Inc. · 1995
  2. This deviceK992682 Modus 2.5 Mandibular Reconstruction SetMedartis AG · 1999
  3. Descendant · cites it directly · 0 of its ownK071612 Modus Trilock 2.0/2.3/2.5Medartis AG · 2007
  4. Descendant · cites it directly · 0 of its ownK013672 Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K071612Modus Trilock 2.0/2.3/2.5Medartis AG · 2007 · cites it directly0descendants
  • K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K946165CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) SystemElekta Instruments, Inc.1995—
0 (this device)K992682Modus 2.5 Mandibular Reconstruction SetMedartis AG1999—
+1K071612Modus Trilock 2.0/2.3/2.5Medartis AG2007—
+1K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200710
FIG. 1 — Lineage of K992682, 1995–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K946165CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System
Summary page 1
…one fixation metallic appliances (21 CFR 888.3030) Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) MODUS® Titanium Osteosynthesis System (K946165) Stryker® Leibinger MARX™ TITANIUM Mandibular Bridging Plate System Synthes® Mandibular Modular Fixation System (K954385) Synth…
Elekta Instruments, Inc.1995—
*K954385Synthes Mandibular Modular Fixation System
Summary page 1
…evices) MODUS® Titanium Osteosynthesis System (K946165) Stryker® Leibinger MARX™ TITANIUM Mandibular Bridging Plate System Synthes® Mandibular Modular Fixation System (K954385) Synthes — 2.4 Mandibular Fracture Set (K961421) Stryker® Leibinger TITANIUM Locking Screw Mandibular Reconstruction Plating Sy…
Synthes (Usa)1996—
*K961421Synthes 2.4 MM Universal Locking Plate System
Summary page 1
…946165) Stryker® Leibinger MARX™ TITANIUM Mandibular Bridging Plate System Synthes® Mandibular Modular Fixation System (K954385) Synthes — 2.4 Mandibular Fracture Set (K961421) Stryker® Leibinger TITANIUM Locking Screw Mandibular Reconstruction Plating System Description of the Device The MODUS® 2.5 M…
Synthes (Usa)1996—
*—Stryker® Leibinger MARX™ TITANIUM Mandibular Bridging Plate System
Named without a submission number
—
*—Stryker® Leibinger TITANIUM Locking Screw Mandibular Reconstruction Plating System
Named without a submission number
—
*—Synthes® Universal Locking Plate System
Named without a submission number
—

Also cleared against K946165: 3 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071612Modus Trilock 2.0/2.3/2.5Medartis AG20070
K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC20020

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 3 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 devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEY

2in 2025

2007: 92008: 72009: 42010: 62011: 52012: 102013: 82014: 62015: 72016: 12017: 52018: 72019: 62020: 62021: 42022: 52023: 22024: 52025: 22026 (partial year): 3
2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007: 115 days median2008: 84 days median2009: 121 days median2010: 199 days median2011: 75 days median2012: 194 days median2013: 126 days median2014: 223 days median2015: 160 days median2017: 190 days median2018: 255 days median2019: 163 days median2020: 198 days median2021: 299 days median2022: 135 days median2024: 159 days median2026 (partial year): 258 days median
2007high 299 (2021) · low 75 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JEY

1in 2020

2008: 32009: 62010: 852013: 12020: 1
2007high 85 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JEY

1,003in 2025

2007: 292008: 242009: 932010: 2152011: 2412012: 4282013: 7662014: 6162015: 7672016: 5582017: 5682018: 6082019: 5952020: 6802021: 4512022: 3442023: 4952024: 6962025: 1,003
2007high 1,003 (2025) · low 24 (2008)2025

MAUDE reports naming product code JEY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079115029
2008784324
20094121693
2010619985215
20115750241
2012101940428
201381261766
201462230616
201571600767
20161—0558
201751900568
201872550608
201961630595
202061981680
202142990451
202251350344
20232—0495
202451590696
20252—01,003
202632580—

What is it indicated for?

The indications for use of the MODUS® 2.5 Reconstruction Set include use in reconstruction surgery, including bone grafting and bridging defects in the mandible after tumor resection or severe infection. It is also indicated for use in mandibular trauma, e.g. unstable, comminuted mandibular fractures and bone loss.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K946165

3 other devices cite the same predicate.

  • K050934Modus Titanium Osteosynthesis SystemMedartis, Inc. · 2005
  • K992683Modus 2.5 Mandibular Trauma SetMedartis AG · 1999
  • K992106Modus System Self-Drilling ScrewsMedartis AG · 1999

More from Medartis AG

42 FDA decisions under this applicant name. See the company

  • K260761APTUS Clavicle System 2.8Medartis AG · 2026
  • K260934TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026
  • K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026
  • K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
  • K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG · 2024

Recent decisions in JEY

The JEY category page

  • K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual…KLS-Martin L.P. · 2026
  • K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
  • K252246Leforte MMF SystemJeil Medical Corporation · 2026
  • K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025

https://510kreport.com/device/K992682 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992682: Modus 2.5 Mandibular Reconstruction Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992682

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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