| K-number | K251554 |
| Device name | Materialise TKA Guide System |
| Applicant | Materialise NV |
| Product code | JWH |
| Device class | Class II |
| Decision date | Jul 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3560 |
The Materialise TKA Guide System is a patient-specific instrumentation and 3D planning software system for total knee replacement surgery. It consists of software (SurgiCase Knee Planner) for pre-surgical planning and hardware (patient-specific guides and models) that assist surgeons in positioning knee replacement components and guiding bone cuts during surgery.
The device uses the same fundamental software technology and code base as the predicate device (K221337), with identical planning functionality and visualization options. The key new feature is software support for restricted kinematic alignment planning philosophy in addition to the mechanical alignment planning already present in the predicate. Hardware remains unchanged from the predicate device.
Not stated in this summary.
The device is substantially equivalent because: (1) the hardware is identical to the predicate with no changes in design, materials, or performance; (2) the software uses the same code base and verification/validation methods as the predicate; (3) the addition of restricted kinematic alignment planning does not affect safety or effectiveness compared to the predicate; and (4) previous biocompatibility, sterility, and performance testing from the predicate apply directly to the subject device.
View the full FDA submission: accessdata.fda.gov