KLS Martin Individual Patient Solutions (IPS) Planning System
FDA 510(k) K201052 · KLS-Martin L.P.
510(k) numberK201052
Submission
- Device name
- KLS Martin Individual Patient Solutions (IPS) Planning System
- Applicant
- KLS-Martin L.P.
Jacksonville, FL, US - Received
- April 21, 2020
- Decision date
- August 31, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PPT – Cranial Surgical Planning And Instrument Guides
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4310
- Specialty
- Neurology
Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.
Other 510(k)s with product code PPT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…PPT · Special | Materialise NV | 01/07/2026SE |
| K182889 | KLS Martin Individual Patient Solutions (IPS) Planning SystemPPT · Traditional | KLS-Martin L.P. | 07/26/2019SE |
| K151285 | VSP Cranial SystemPPT · Traditional | 3D Systems, Inc. | 09/23/2016SE |
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| K250620 | KLS Martin Ixos SystemHRS · Traditional | 08/15/2025SE |
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| 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 (K201052) received a 510(k) decision of Substantially Equivalent on August 31, 2020, 132 days after the submission was received.
What is the product code of K201052?
The FDA product code is PPT – Cranial Surgical Planning And Instrument Guides, a Class II (moderate risk) device regulated under 21 CFR 882.4310.