Signature Planner, Signature Guides
FDA 510(k) K140257 · Materialise NV
510(k) numberK140257
Submission
- Device name
- Signature Planner, Signature Guides
- Applicant
- Materialise NV
Leuven, BE - Received
- February 3, 2014
- Decision date
- April 2, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3565
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | Smith & Nephew, Inc. | 09/08/2026SE |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial SystemMBH · Traditional | Microport Orthopedics, Inc. | 08/21/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | Zimmer, Inc. | 05/28/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | Zimmer, Inc. | 03/09/2026SE |
| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | Medacta International S.A. | 02/26/2026SE |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 02/18/2026SE |
| K253239 | Active-V Total Knee System; World Total Knee SystemMBH · Traditional | Signature Orthopaedics Pty, Ltd. | 12/23/2025SE |
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | Ortho Development Corp. | 12/19/2025SE |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional | Maxx Orthopedics, Inc. | 10/31/2025SE |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/24/2025SE |
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| 510(k) | Device | Decision |
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| K251964 | Mimics Thoracic PlannerLLZ · Traditional | 03/12/2026SE |
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…PPT · Special | 01/07/2026SE |
| K253793 | Materialise TKA Guide SystemJWH · Special | 01/06/2026SE |
| K251554 | Materialise TKA Guide SystemJWH · Traditional | 07/14/2025SE |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional | 02/21/2025SE |
| K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 10/18/2024SE |
| K223427 | Mimics Enlight CMFLLZ · Traditional | 05/31/2024SE |
| K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 05/22/2024SE |
| K233217 | Mimics Cardiac PlannerLLZ · Traditional | 02/12/2024SE |
Questions and answers
When was Signature Planner, Signature Guides cleared by the FDA?
Signature Planner, Signature Guides (K140257) received a 510(k) decision of Substantially Equivalent on April 2, 2014, 58 days after the submission was received.
What is the product code of K140257?
The FDA product code is MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3565.