FDA device listing
BKS Total PSI,Lima Personalized Surgical Instruments,Materialise Knee Guides,Materialise Knee Guide System,Materialise…
FDA device listing 1687114807 · MATERIALISE N.V.
Key facts
| Proprietary names | BKS Total PSI,Lima Personalized Surgical Instruments,Materialise Knee Guides,Materialise Knee Guide System,Materialise Knee Planner,Materialise Knee Platform,Materialise SurgiCase Knee Module,Materialise SurgiCase Knee Planner,Materialise TKA Guide Planner,Materialise TKA Guides,Materialise TKA Guides and Models,Materialise TKA Guide System,Signature Guides,Signature Planner,SurgiCase Knee… |
|---|---|
| Owner/operator | MATERIALISE N.V. |
| Owner/operator number | 9029485 |
| Premarket submissions | K253793 |
| Product codes | JWH, MBH, OIY, OOG |
| Device names | JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, OIY - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive, OOG - Knee Arthroplasty Implantation System |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3560, 888.3565 |
| Review panels | Orthopedic |
| Registered establishments | Materialise Colombia S.A.S, MATERIALISE N.V., Materialise Sdn Bhd, Materialise Ukraine, Rep. office, Materialise USA, LLC. |
| Establishment registrations | 3003998208, 3005718816, 3009555440, 3009555447, 3011724582 |
| FEI numbers | 3003998208, 3005718816, 3009555440, 3009555447, 3011724582 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database