510(k) · Cleared
ClearedKLS Martin Individual Patient Solutions
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 Nov 21, 2017 as substantially equivalent to K032442 (KLS-Martin L.P., 2003) after a 336-day review. Its family tree reaches back 4 generations to 1996. 9 later devices descend from it.
- Decided
- Nov 21, 2017
- Review
- 336 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954385 (1996). 12 ancestors in all, the oldest K943347 (1994). 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 3 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 2 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 1 generation backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- This deviceK163579 KLS Martin Individual Patient SolutionsKLS Martin L.P. · 2017
- Descendant · cites it directly · 7 of its ownK191028 KLS Martin Individual Patient SolutionsKLS-Martin L.P. · 2019
- Descendant · 2 generations on · 3 of its ownK210731 KLS Martin Individual Patient SolutionsKLS-Martin L.P. · 2022
- Descendant · 2 generations on · 1 of its ownK203282 TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S · 2021
- Descendant · 3 generations on · 0 of its ownK260137 KLS Martin IPS Oral-Max Implants - MR Conditional; Individual…KLS-Martin L.P. · 2026
- Descendant · 3 generations on · 0 of its ownK253206 METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K191028KLS Martin Individual Patient SolutionsKLS-Martin L.P. · 2019 · cites it directly7descendants
- K210731KLS Martin Individual Patient SolutionsKLS-Martin L.P. · 2022 · 2 generations on3descendants
- K203282TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S · 2021 · 2 generations on1descendant
- K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P. · 2026 · 3 generations on0descendants
- K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −3 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −2 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −1 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| 0 (this device) | K163579 | KLS Martin Individual Patient Solutions | KLS Martin L.P. | 2017 | — |
| +1 | K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2019 | — |
| +2 | K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2022 | — |
| +2 | K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | 2021 | — |
| +3 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient… | KLS-Martin L.P. | 2026 | — |
| +3 | K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K032442 | KLS-Martin Mandibular/Reconstruction System IISummary page 4…fication Name: Bone plate (21 CFR 872.4760) Regulatory Class: II Product Code: JEY Predicate Device: KLS Martin Mandibular Reconstruction System II (K032442) Reference Devices: Patient Contoured Mesh (K062570) KLS Mini Osteosynthesis System (K943347)… | 2003 |
| † | K062570 | Patient Contoured Mesh (PCM) | 2006 |
| † | K943347 | KLS Mini Osteosynthesis System | 1994 |
| † | K971297 | Centre-Drive Drill-Free Screw | 1997 |
| † | K153482 | KLS Martin Thoracic Plating System | 2016 |
What descends from it? (9)
2 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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K191028 (KLS-Martin L.P., 2019) has gone furthest, with 7 descendants of its own.
- 6 other devices also cite its predicate K032442.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
KLS Martin Individual Patient Solutions implant devices are intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163579 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163579: KLS Martin Individual Patient Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163579
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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