510(k) · Cleared
ClearedMod Line of Molina Distractors, 51-600 Series
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 Feb 15, 2000 as substantially equivalent to K945500 (Wells Johnson Co., 1995) after a 68-day review. Its family tree reaches back 1 generation to 1995. 7 later devices descend from it.
- Decided
- Feb 15, 2000
- Review
- 68 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945500 (1995). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK945500 Wells Johnson Fixation SystemWells Johnson Co. · 1995
- This deviceK994154 Mod Line of Molina Distractors, 51-600 SeriesKLS-Martin L.P. · 2000
- Descendant · cites it directly · 3 of its ownK034027 KLS Martin 3DX External Distraction SystemKLS-Martin L.P. · 2004
- Descendant · cites it directly · 2 of its ownK063792 Osteomed External Mandibular Distraction SystemOsteomed LP · 2007
- Descendant · cites it directly · 2 of its ownK062851 Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP · 2006
- Descendant · 2 generations on · 1 of its ownK133398 Stryker Pediatric Mandible DistractorStryker · 2014
- Descendant · 2 generations on · 1 of its ownK123885 Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K034027KLS Martin 3DX External Distraction SystemKLS-Martin L.P. · 2004 · cites it directly3descendants
- K063792Osteomed External Mandibular Distraction SystemOsteomed LP · 2007 · cites it directly2descendants
- K062851Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedOsteomed LP · 2006 · cites it directly2descendants
- K133398Stryker Pediatric Mandible DistractorStryker · 2014 · 2 generations on1descendant
- K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945500 | Wells Johnson Fixation System | Wells Johnson Co. | 1995 | — |
| 0 (this device) | K994154 | Mod Line of Molina Distractors, 51-600 Series | KLS-Martin L.P. | 2000 | — |
| +1 | K034027 | KLS Martin 3DX External Distraction System | KLS-Martin L.P. | 2004 | — |
| +1 | K063792 | Osteomed External Mandibular Distraction System | Osteomed LP | 2007 | — |
| +1 | K062851 | Osteomed Pediatric Intraoral Mandibular Distraction System, Extended | Osteomed LP | 2006 | — |
| +2 | K133398 | Stryker Pediatric Mandible Distractor | Stryker | 2014 | — |
| +2 | K123885 | Osteomed Smartflex Cranial Spring Distractor | Osteomed LP | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K945500 | Wells Johnson Fixation SystemSummary page 1…vices, Inc. (RMS) 3234 Ella Lane New Port Richey, FL 34655 Phone: 727-376-4154 Fax: 727-376-7186 Art Ward December 2,1999 MOD Line of Molina Distractors Plate, Bone K945500 Molina Distractor Wells Johnson The KLS-Martin Molina Distractor is a mandibular fixation device consisting of Uni-directional a… | 1995 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 KLS-Martin Molina Distractors are intended for use as external distractors for bone elongation. It is used for the correction of asymmetric mandibular deficiencies and mandibular hypoplasia. The devices are external and are anchored to the mandible by external pins.
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/K994154 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994154: Mod Line of Molina Distractors, 51-600 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994154
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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