510(k) · Cleared
ClearedBruges Distraction - Anchoring - Osteosynthesis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Azary Technologies, LLC · JEY Plate, Bone
Cleared on Apr 8, 2002 as substantially equivalent to K972166 (Howmedica Leibinger, Inc., 1997) and 2 other predicates after a 153-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- Apr 8, 2002
- Review
- 153 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K792561 (1979). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 3 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 2 generations backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- 1 generation backK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- This deviceK013672 Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −3 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −2 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| −1 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| 0 (this device) | K013672 | Bruges Distraction - Anchoring - Osteosynthesis System | Azary Technologies, LLC | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K972166 | Guerrero - Bell DistractorSummary page 1…3)] The subject device is substantially equivalent to the following devices: CIE Subject Device Name 510k Howmedica Leibinger Guerrero-Bell Distractor (or Dynaform) K972166 Martin Zurich Distraction System K010139 Medartis MODUS Mandibular Reconstruction System K992682 Description of the Device [… | 1997 |
| * | K010139 | Zurich Distraction SystemSummary page 1…ivalent to the following devices: CIE Subject Device Name 510k Howmedica Leibinger Guerrero-Bell Distractor (or Dynaform) K972166 Martin Zurich Distraction System K010139 Medartis MODUS Mandibular Reconstruction System K992682 Description of the Device [21 CFR 807.92(a)(4)] The subject device in… | 2001 |
| * | K992682 | Modus 2.5 Mandibular Reconstruction SetSummary page 1…e 510k Howmedica Leibinger Guerrero-Bell Distractor (or Dynaform) K972166 Martin Zurich Distraction System K010139 Medartis MODUS Mandibular Reconstruction System K992682 Description of the Device [21 CFR 807.92(a)(4)] The subject device includes several different designs of implantable distractor… | 1999 |
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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 16 ancestors has a recall.
- 3 other devices also cite its predicate K972166.
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 subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate).
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/K013672 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013672: Bruges Distraction - Anchoring - Osteosynthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013672
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026