ELEOS™
- Primary DI
- B278PT2000002M0
- Brand
- ELEOS™
- Company
- ONKOS SURGICAL, INC.
- Model
- PT-20000-02M
- Catalog number
- PT-20000-02M
- Device description
- ELEOS™ SEGMENTAL PROXIMAL TIBIA WITH BIOGRIP™ POROUS TECHNOLOGY
- Published
- 2021-01-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| KRO | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B278PT2000002M0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Coated knee tibia prosthesis | A sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation may be performed with or without bone cement. |
Sterilization Methods
| Method |
|---|
| Radiation Sterilization |
Regulatory Flags
- DUNS number
- 080254074
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- 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 |
|---|
| B278DV3500004N0 | My3D® Personalized Pelvic Reconstruction | DV-35000-04N | | 2025-09-22 |
| B278DVMOD3504N0 | My3D® Personalized Pelvic Reconstruction | DV-MOD35-04N | | 2025-09-22 |
| B278DVRDG3504N0 | My3D® Personalized Pelvic Reconstruction | DV-RGD35-04N | | 2025-09-22 |
| B278AMMS040MF0 | ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY | AM-MS-040MF | | 2024-12-13 |
| B278AMMS050MF0 | ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY | AM-MS-050MF | | 2024-12-13 |
| B278AMMS060MF0 | ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY | AM-MS-060MF | | 2024-12-13 |
| B278AMMS070MF0 | ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY | AM-MS-070MF | | 2024-12-13 |
| B278IMBCEXSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | imbc/ExSm | IMBC-EXSM | 2024-07-23 |
| B278JTSDFLSTD0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | JTSDF-L-STD | JTSDF-L-STD | 2024-07-23 |
| B278TMKTPEXSM50 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | tmktp/ExSm5 | TMKTP-EXSM5 | 2024-07-23 |
| B278IMARDRL0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | imardrl | IMARDRL | 2024-07-22 |
| B278IMAXCP0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | imaxcp | IMAXCP | 2024-07-22 |
| B278IMBCSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | imbc/Sm | IMBC-SM | 2024-07-22 |
| B278IMPBIMPEXSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | impbimp/ExSm | IMPBIMP-EXSM | 2024-07-22 |
| B278IMPBIMPSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | impbimp/Sm | IMPBIMP-SM | 2024-07-22 |
| B278JTSDFLSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | JTSDF-L-SM | JTSDF-L-SM | 2024-07-22 |
| B278JTSDFRSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | JTSDF-R-SM | JTSDF-R-SM | 2024-07-22 |
| B278JTSDFRXSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | JTSDF-R-XSM | JTSDF-R-XSM | 2024-07-22 |
| B278JTSDRIVEUNIT0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | MLE3 | JTS-DRIVE-UNIT | 2024-07-22 |
| B278PIN0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | ictjigsh | PIN | 2024-07-22 |
Other Devices Sharing Product Codes