Identity
- Trade Name
- iTotal® PS iPoly® Insert Kit FDA UDI
- Generic Name
- Total knee prosthesis implantation guide-instrument kit FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- RPS010200001 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- RPS0102000 FDA UDI
- Primary DI / UDI-DI
- M572RPS0102000011 FDA UDI
- 510(k) Number
- K161668 FDA UDI
- FDA Product Code
- JWH FDA UDIOOG 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: Tibial insertTotal knee prosthesis implantation guide-instrument kit
iTotal® PS iPoly® Insert 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.
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- AVID TruCustom — AVID MEDICAL, INC. · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC · Class II
Cleared under the same submission
K161668 also covers:
- iTotal PS Knee Replacement System — Conformis, Inc.
- iTotal® PS Tibial Keel Punch Tip — Conformis, Inc.
- iTotal® PS Tibial Keel Punch Tip — Conformis, Inc.
- iTotal® PS Tibial Keel Punch Tip — 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® Poly Impactor Tip — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA UDI 282b5aa4-e725-48fc-95be-cef395d0625e 37 fields · synced May 30, 2026