| K-number | K253793 |
| Device name | Materialise TKA Guide System |
| Applicant | Materialise NV |
| Product code | JWH |
| Device class | Class II |
| Decision date | Jan 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3560 |
The Materialise TKA Guide System is a medical device for total knee arthroplasty that consists of software (SurgiCase Knee Planner) and hardware (patient-specific guides and models). The software generates a pre-surgical plan based on MRI or CT images, allowing surgeons to visualize and customize component positioning. The hardware guides intra-operative positioning and bone preparation for multiple compatible knee prosthesis systems.
The subject device employs the same fundamental planning functionality, visualization options, and code base as the predicate device K251554. The main difference is the addition of three new Zimmer Biomet implant components (Persona OsseoTi Keel Tibia, Persona Cemented Keel Tibia, and Persona PPS Femur) to the software selection menu and hardware compatibility. Compatibility with several discontinued prosthesis systems has been removed.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov