Identity
- Trade Name
- iTotal® PS Tibial Tray Kit FDA UDI
- Generic Name
- Total knee prosthesis implantation guide-instrument kit FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- RPS101111301 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- RPS1011113 FDA UDI
- Primary DI / UDI-DI
- M572RPS1011113011 FDA UDI
- FDA Product Code
- OOG FDA UDIJWH FDA UDI
- GMDN Term
- Total knee prosthesis implantation guide-instrument kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Uncoated knee tibia prosthesis, metallicTotal knee prosthesis implantation guide-instrument kit
iTotal® PS Tibial Tray Kit by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total knee prosthesis implantation guide-instrument kit.
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Cleared under the same submission
K142161 also covers:
- iTotal® CR Tibial Tray Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
- iTotal® CR iPoly™ Insert Kit — Conformis, Inc.
K142404 also covers:
- iTotal® PS Femoral Kit — Conformis, Inc.
- iTotal® PS iPoly™ Insert Kit — Conformis, Inc.
- iTotal® PS iPoly™ Insert Kit — Conformis, Inc.
- iTotal® PS iPoly™ Insert Kit — Conformis, Inc.
- iTotal® PS iPoly™ Insert Kit — Conformis, Inc.
- iTotal® PS iPoly™ Insert Kit — Conformis, Inc.
- iTotal® PS iPoly™ Insert Kit — Conformis, Inc.
- iTotal® PS iPoly™ Insert Kit — Conformis, Inc.
- iTotal® PS iPoly™ Insert Kit — Conformis, Inc.
- iTotal® PS iPoly™ Insert Kit — Conformis, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA UDI ebf8d374-a087-4922-8b50-3776a17e2ccc 37 fields · synced May 30, 2026