510(k) K221337 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Materialise TKA Guide System
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Jul 5, 2022 |
| Received | May 9, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221337
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2023 | Materialise N.V. MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-oper Completed |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.