KLS Martin Individual Patient Solutions (IPS) Planning System
FDA 510(k) K181241 · KLS-Martin L.P.
510(k) numberK181241
Submission
- Device name
- KLS Martin Individual Patient Solutions (IPS) Planning System
- Applicant
- KLS-Martin L.P.
Jacksonville, FL, US - Received
- May 10, 2018
- Decision date
- September 13, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K231520 | tmCMF SolutionDZJ · Traditional | Techmah Cmf | 10/02/2023SE |
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| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | Medcad | 03/07/2023SE |
| K220366 | EmbedMedDZJ · Traditional | 3D Lifeprints UK , Ltd. | 09/30/2022SE |
| K220648 | OMF ASP SystemDZJ · Traditional | Vha Dean | 08/11/2022SE |
| K212570 | OsteoPlan SystemDZJ · Traditional | Osteomed, LLC | 02/11/2022SE |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional | Centermed, Inc. | 06/28/2021SE |
More from Centermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…JEY · Traditional | 08/17/2026SE |
| 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 |
Questions and answers
When was KLS Martin Individual Patient Solutions (IPS) Planning System cleared by the FDA?
KLS Martin Individual Patient Solutions (IPS) Planning System (K181241) received a 510(k) decision of Substantially Equivalent on September 13, 2018, 126 days after the submission was received.
What is the product code of K181241?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.