Signature
- Primary DI
- E31442422415
- Brand
- Signature
- Company
- Materialise NV
- Model
- 42-422415
- Catalog number
- 42-422415
- Device description
- CT Bone Models
- Published
- 2026-09-24
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| 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 |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | 2 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | 2 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | 2 |
| OOG | Knee Arthroplasty Implantation System | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K102795 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| E31442422415 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Custom-made organ/bone anatomy model | A model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 373139427
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| E31442100200 | Signature | 42-100200 | 42-100200 | 2026-09-24 |
| E31442100300 | Signature | 42-100300 | 42-100300 | 2026-09-24 |
| E31442411410 | Signature | 42-411410 | 42-411410 | 2026-09-24 |
| E31442422450 | Signature | 42-422450 | 42-422450 | 2026-09-24 |
| E31442422451 | Signature | 42-422451 | 42-422451 | 2026-09-24 |
| E31442422452 | Signature | 42-422452 | 42-422452 | 2026-09-24 |
| E31442422453 | Signature | 42-422453 | 42-422453 | 2026-09-24 |
| E31442422455 | Signature | 42-422455 | 42-422455 | 2026-09-24 |
| E31442422456 | Signature | 42-422456 | 42-422456 | 2026-09-24 |
| E31442422457 | Signature | 42-422457 | 42-422457 | 2026-09-24 |
| E31442422458 | Signature | 42-422458 | 42-422458 | 2026-09-24 |
| E31442422460 | Signature | 42-422460 | 42-422460 | 2026-09-24 |
| E31442422461 | Signature | 42-422461 | 42-422461 | 2026-09-24 |
| E31442422462 | Signature | 42-422462 | 42-422462 | 2026-09-24 |
| E31442422463 | Signature | 42-422463 | 42-422463 | 2026-09-24 |
| E31442422465 | Signature | 42-422465 | 42-422465 | 2026-09-24 |
| E31442422466 | Signature | 42-422466 | 42-422466 | 2026-09-24 |
| E31442422467 | Signature | 42-422467 | 42-422467 | 2026-09-24 |
| E31442422468 | Signature | 42-422468 | 42-422468 | 2026-09-24 |
| E31442422470 | Signature | 42-422470 | 42-422470 | 2026-09-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| E31442411410 | Signature | Materialise NV | MBH | 2026-09-24 |
| E31442411410 | Signature | Materialise NV | OOG | 2026-09-24 |
| E31442411410 | Signature | Materialise NV | OIY | 2026-09-24 |
| E31442411410 | Signature | Materialise NV | JWH | 2026-09-24 |
| E31442422450 | Signature | Materialise NV | OIY | 2026-09-24 |
| E31442422450 | Signature | Materialise NV | OOG | 2026-09-24 |
| E31442422450 | Signature | Materialise NV | MBH | 2026-09-24 |
| E31442422450 | Signature | Materialise NV | JWH | 2026-09-24 |
| E31442422451 | Signature | Materialise NV | JWH | 2026-09-24 |
| E31442422451 | Signature | Materialise NV | MBH | 2026-09-24 |
| E31442422451 | Signature | Materialise NV | OOG | 2026-09-24 |
| E31442422451 | Signature | Materialise NV | OIY | 2026-09-24 |
| E31442422452 | Signature | Materialise NV | OIY | 2026-09-24 |
| E31442422452 | Signature | Materialise NV | OOG | 2026-09-24 |
| E31442422452 | Signature | Materialise NV | JWH | 2026-09-24 |
| E31442422452 | Signature | Materialise NV | MBH | 2026-09-24 |
| E31442422453 | Signature | Materialise NV | JWH | 2026-09-24 |
| E31442422453 | Signature | Materialise NV | MBH | 2026-09-24 |
| E31442422453 | Signature | Materialise NV | OOG | 2026-09-24 |
| E31442422453 | Signature | Materialise NV | OIY | 2026-09-24 |
| E31442422455 | Signature | Materialise NV | OOG | 2026-09-24 |
| E31442422455 | Signature | Materialise NV | OIY | 2026-09-24 |
| E31442422455 | Signature | Materialise NV | MBH | 2026-09-24 |
| E31442422455 | Signature | Materialise NV | JWH | 2026-09-24 |
| E31442422456 | Signature | Materialise NV | JWH | 2026-09-24 |
| E31442422456 | Signature | Materialise NV | MBH | 2026-09-24 |
| E31442422456 | Signature | Materialise NV | OOG | 2026-09-24 |
| E31442422456 | Signature | Materialise NV | OIY | 2026-09-24 |
| E31442422457 | Signature | Materialise NV | JWH | 2026-09-24 |
| E31442422457 | Signature | Materialise NV | MBH | 2026-09-24 |