510(k) · Cleared
ClearedWells Johnson Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wells Johnson Co. · JEY Plate, Bone
Cleared on Sep 21, 1995 after a 316-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 26 later devices descend from it.
- Decided
- Sep 21, 1995
- Review
- 316 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 3 citing it directly.
- This deviceK945500 Wells Johnson Fixation SystemWells Johnson Co. · 1995
- Descendant · cites it directly · 23 of its ownK960297 Mandibular Bone Distractor IIHowmedica Corp. · 1996
- Descendant · cites it directly · 17 of its ownK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- Descendant · 2 generations on · 11 of its ownK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- Descendant · 2 generations on · 8 of its ownK972154 Cohen DistractorHowmedica Leibinger, Inc. · 1997
- Descendant · cites it directly · 7 of its ownK994154 Mod Line of Molina Distractors, 51-600 SeriesKLS-Martin L.P. · 2000
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K960297Mandibular Bone Distractor IIHowmedica Corp. · 1996 · cites it directly23descendants
- K964649Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997 · cites it directly17descendants
- K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997 · 2 generations on11descendants
- K972154Cohen DistractorHowmedica Leibinger, Inc. · 1997 · 2 generations on8descendants
- K994154Mod Line of Molina Distractors, 51-600 SeriesKLS-Martin L.P. · 2000 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945500 | Wells Johnson Fixation System | Wells Johnson Co. | 1995 | — |
| +1 | K960297 | Mandibular Bone Distractor II | Howmedica Corp. | 1996 | — |
| +1 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| +2 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| +2 | K972154 | Cohen Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| +1 | K994154 | Mod Line of Molina Distractors, 51-600 Series | KLS-Martin L.P. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (26)
See all 263 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?
- Of its descendants, K960297 (Howmedica Corp., 1996) has gone furthest, with 23 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/K945500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945500: Wells Johnson Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945500
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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