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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
- Joint prosthesis implantation kit, single-use FDA UDI
- Device Name
- ITOTAL IDENTITY PS JIGS FDA UDI
- Model / Reference
- TPS000D00101 FDA UDI
- Description
- ITOTAL IDENTITY PS JIGS FDA UDI
Identifiers
- Catalog Number
- TPS-000-D001 FDA UDI
- Primary DI / UDI-DI
- M572TPS000D001011 FDA UDI
- 510(k) Number
- K201023 FDA UDI
- FDA Product Code
- JWH FDA UDIOOG FDA UDIOIY FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, single-use 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
Category: Joint prosthesis implantation kit, single-use
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 Joint prosthesis implantation kit, single-use.
- OvertureTi — OVERTURE ORTHOPAEDICS
- Dekalb Knee Pack — PACKROOM LLC
- Argo Knotless — Conmed Corporation · Class IIa
- Instruments IIa — Newclip Technics SAS · Class IIa
- CC-Hook Right — Xiros Limited · Class IIa
- Femoral Epimandrel — Episurf Operations AB · Class II
- Blunt pin — Si-Bone Inc. · Class IIa
- Y-KNOT — Conmed Corporation · Class IIa
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 f3808a00-c4b9-4079-9b00-74001c55dd68 36 fields · synced Jun 8, 2026