FDA UDI
In Commercial Distribution
🇺🇸 United States
iTotal Identity Posterior Stabilized Knee Replacement System
DI: M572TPS3011113011
·
Model: TPS301111301
·
Conformis, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iTotal Identity Posterior Stabilized Knee Replacement System
- Primary DI
- M572TPS3011113011
- Version / Model
- TPS301111301
- Catalog Number
- TPS-301-1113
- Company Name
- Conformis, Inc.
- Labeler DUNS
- 808821883
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-10
- Public Version
- 1
- Public Version Date
- 2020-07-20
- Public Version Status
- New
- Public Device Record Key
- a79d5a05-53e8-4ce6-b86a-91699f0bb68b
Device Description
ITOTAL IDENTITY PS TIBIAL TRAY, (TITANIUM, CEMENTED)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | 888.3560 | 2 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | 888.3560 | 2 |
| OOG | Knee Arthroplasty Implantation System | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33666 | Uncoated knee tibia/insert 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 not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it includes a polyethylene (PE) insert/platform for femoral articulation. Device implantation is intended to be performed with bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M572TPS3011113011 | HIBCC |
Customer Contacts
- Phone
- 781-345-0001
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201023 | 000 |