KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions
FDA 510(k) K260137 · KLS-Martin L.P.
510(k) numberK260137
Submission
- Device name
- KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions
- Applicant
- KLS-Martin L.P.
Jacksonville, FL, US - Received
- January 16, 2026
- Decision date
- August 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JEY
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|---|---|---|---|
| K253206 | METICULY Patient-specific CMF solutionJEY · Traditional | Meticuly Co., Ltd. | 07/25/2026SE |
| K252246 | Leforte MMF SystemJEY · Traditional | Jeil Medical Corporation | 04/02/2026SE |
| K253373 | Southern Craniomaxillofacial (CMF) SystemJEY · Traditional | Southern Medical (Pty) , Ltd. | 12/19/2025SE |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…JEY · Traditional | Inion OY | 11/07/2025SE |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled)JEY · Traditional | KLS-Martin L.P. | 08/16/2024SE |
| K240651 | MRI UniversalJEY · Traditional | Stryker Leibinger GmbH & Co KG | 07/12/2024SE |
| K233874 | tmCMF SolutionJEY · Traditional | Techmah Cmf | 07/11/2024SE |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implantJEY · Traditional | Meticuly Co., Ltd. | 04/30/2024SE |
| K232350 | Stryker Facial iD SystemJEY · Traditional | Stryker Craniomaxillofacial | 01/13/2024SE |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemJEY · Traditional | Medcad | 09/26/2023SE |
More from Medcad
| 510(k) | Device | Decision |
|---|---|---|
| K254162 | KLS Martin Ixos SystemHRS · Traditional | 02/20/2026SE |
| K253660 | KLS Martin Pure Pectus SystemHRS · Traditional | 02/20/2026SE |
| K250988 | KLS Martin Pure Pectus SystemHRS · Traditional | 12/11/2025SE |
| K250865 | KLS Martin IPS Forearm SystemHRS · Traditional | 11/14/2025SE |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…GXN · Traditional | 11/10/2025SE |
| K250620 | KLS Martin Ixos SystemHRS · Traditional | 08/15/2025SE |
| K233721 | KLS Martin Drill-Free MMF ScrewDZL · Traditional | 09/17/2024SE |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled)JEY · Traditional | 08/16/2024SE |
| K241018 | KLS Martin Orthopedic Implants - MR ConditionalHRS · Traditional | 07/12/2024SE |
| K230211 | CranioXpandPBJ · Traditional | 11/21/2023SE |
Questions and answers
When was KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions cleared by the FDA?
KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions (K260137) received a 510(k) decision of Substantially Equivalent on August 17, 2026, 213 days after the submission was received.
What is the product code of K260137?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.