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iTotal Identity Posterior Stabilized Knee Replacement System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- iTotal Identity Posterior Stabilized Knee Replacement System FDA UDI
- Generic Name
- Uncoated knee tibia/insert prosthesis FDA UDI
- Device Name
- ITOTAL IDENTITY PS TIBIAL TRAY, (TITANIUM, CEMENTED) FDA UDI
- Model / Reference
- TPS301111301 FDA UDI
- Description
- ITOTAL IDENTITY PS TIBIAL TRAY, (TITANIUM, CEMENTED) FDA UDI
Identifiers
- Catalog Number
- TPS-301-1113 FDA UDI
- Primary DI / UDI-DI
- M572TPS3011113011 FDA UDI
- 510(k) Number
- K201023 FDA UDI
- FDA Product Code
- JWH FDA UDIOIY FDA UDIOOG FDA UDI
- GMDN Term
- Uncoated knee tibia/insert prosthesis 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
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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/insert prosthesis
iTotal Identity Posterior Stabilized Knee Replacement System by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee tibia/insert prosthesis.
- Arthrex® — Arthrex, Inc. · Class II
- Vanguard Complete Knee System — Biomet Orthopedics, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- LOSPA Total Knee System — Corentec Co., Ltd · Class II
- LOSPA Total Knee System — Corentec Co., Ltd · Class II
- LOSPA Modular Knee System — Corentec Co., Ltd · Class II
- Arthrex® — Arthrex, Inc. · Class II
- LOSPA Modular Knee System — Corentec Co., Ltd · Class II
Cleared under the same submission
K201023 also covers:
- iTotal Identity PS — Conformis, Inc.
- iTotal Identity Posterior Stabilized Knee Replacement System — Conformis, Inc.
- iTotal Identity Posterior Stabilized Knee Replacement System — Conformis, Inc.
- iTotal Identity Posterior Stabilized Knee Replacement System — Conformis, Inc.
- iTotal Identity Posterior Stabilized Knee Replacement System — Conformis, Inc.
- iTotal Identity Posterior Stabilized Knee Replacement System — Conformis, Inc.
- iTotal Identity Posterior Stabilized Knee Replacement System — Conformis, Inc.
- iTotal Identity Posterior Stabilized Knee Replacement System — Conformis, Inc.
- iTotal Identity Posterior Stabilized Knee Replacement System — Conformis, Inc.
- iTotal Identity Posterior Stabilized Knee Replacement System — Conformis, Inc.
- iTotal Identity Posterior Stabilized Knee Replacement System — Conformis, Inc.
- iTotal Identity Posterior Stabilized Knee Replacement System — 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 a79d5a05-53e8-4ce6-b86a-91699f0bb68b 36 fields · synced May 30, 2026