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 22, 2019 as substantially equivalent to K163579 (KLS Martin L.P., 2017) after a 218-day review. Its family tree reaches back 5 generations to 1996. 7 later devices descend from it.
- Decided
- Nov 22, 2019
- Review
- 218 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954385 (1996). 13 ancestors in all, the oldest K943347 (1994). 7 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 4 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 3 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 2 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 1 generation backK163579 KLS Martin Individual Patient SolutionsKLS Martin L.P. · 2017
- This deviceK191028 KLS Martin Individual Patient SolutionsKLS-Martin L.P. · 2019
- Descendant · cites it directly · 3 of its ownK210731 KLS Martin Individual Patient SolutionsKLS-Martin L.P. · 2022
- Descendant · cites it directly · 1 of its ownK203282 TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S · 2021
- Descendant · 2 generations on · 0 of its ownK260137 KLS Martin IPS Oral-Max Implants - MR Conditional; Individual…KLS-Martin L.P. · 2026
- Descendant · 2 generations on · 0 of its ownK253206 METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK232350 Stryker Facial iD SystemStryker Craniomaxillofacial · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K210731KLS Martin Individual Patient SolutionsKLS-Martin L.P. · 2022 · cites it directly3descendants
- K203282TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S · 2021 · cites it directly1descendant
- K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P. · 2026 · 2 generations on0descendants
- K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026 · 2 generations on0descendants
- K232350Stryker Facial iD SystemStryker Craniomaxillofacial · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −4 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −3 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −2 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −1 | K163579 | KLS Martin Individual Patient Solutions | KLS Martin L.P. | 2017 | — |
| 0 (this device) | K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2019 | — |
| +1 | K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2022 | — |
| +1 | K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | 2021 | — |
| +2 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient… | KLS-Martin L.P. | 2026 | — |
| +2 | K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | 2026 | — |
| +2 | K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | 2024 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K163579 | KLS Martin Individual Patient SolutionsSummary page 4…II Product Code: JEY Regulation Number: 21 CFR 872.4760 Primary Predicate: KLS Martin Individual Patient Solutions (K163579) Reference Devices: TruMatch CMF Titanium 3D Printed Implant (K173039) KLS Martin… | 2017 |
| † | K173039 | TruMatch CMF Titanium 3D Printed Implant | 2018 |
| † | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM) | 1994 |
| † | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | 2019 |
| † | K161634 | IPS CaseDesigner | 2016 |
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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K210731 (KLS-Martin L.P., 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K163579.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191028: KLS Martin Individual Patient Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191028
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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