510(k) · Cleared
ClearedMolina Orbital Malar Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · JEY Plate, Bone
Cleared on Jan 23, 2001 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jan 23, 2001
- Review
- 39 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 5 citing it directly.
- This deviceK003883 Molina Orbital Malar DistractorKLS-Martin L.P. · 2001
- Descendant · cites it directly · 3 of its ownK092743 The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial · 2010
- Descendant · cites it directly · 2 of its ownK121304 Osteomed Cranial Distraction SystemOsteomed · 2012
- Descendant · cites it directly · 1 of its ownK161470 Internal Distraction - SterileKLS Martin L.P. · 2016
- Descendant · 2 generations on · 1 of its ownK133398 Stryker Pediatric Mandible DistractorStryker · 2014
- Descendant · cites it directly · 1 of its ownK123885 Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial · 2010 · cites it directly3descendants
- K121304Osteomed Cranial Distraction SystemOsteomed · 2012 · cites it directly2descendants
- K161470Internal Distraction - SterileKLS Martin L.P. · 2016 · cites it directly1descendant
- K133398Stryker Pediatric Mandible DistractorStryker · 2014 · 2 generations on1descendant
- K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003883 | Molina Orbital Malar Distractor | KLS-Martin L.P. | 2001 | — |
| +1 | K092743 | The Leibinger Advance Internal Midface Distraction System | Stryker Craniomaxillofacial | 2010 | — |
| +1 | K121304 | Osteomed Cranial Distraction System | Osteomed | 2012 | — |
| +1 | K161470 | Internal Distraction - Sterile | KLS Martin L.P. | 2016 | — |
| +2 | K133398 | Stryker Pediatric Mandible Distractor | Stryker | 2014 | — |
| +1 | K123885 | Osteomed Smartflex Cranial Spring Distractor | Osteomed LP | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092743 | The Leibinger Advance Internal Midface Distraction System | 2010 | 3 |
| K121304 | Osteomed Cranial Distraction System | 2012 | 2 |
| K161470 | Internal Distraction - Sterile | 2016 | 1 |
| K123885 | Osteomed Smartflex Cranial Spring Distractor | 2013 | 1 |
| K121235 | Leibinger Advance Internal Midface Distraction System | 2014 | 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?
- Of its descendants, K092743 (Stryker Craniomaxillofacial, 2010) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K003883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003883: Molina Orbital Malar Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003883
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026