Identity
- Trade Name
- iTotal® Patella Sizer FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- iTotal® 29mm Patella Sizer Reusable Instrument FDA UDI
- Model / Reference
- 1080-528 FDA UDI
- Description
- iTotal® 29mm Patella Sizer Reusable Instrument FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850268007132 FDA UDI
- 510(k) Number
- K160025 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 29 Millimeter FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusablePatella prosthesis trial
iTotal® Patella Sizer by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patella prosthesis trial.
- Unity Knee System — OMNIlife science, Inc. · Class I
- BIOMET SERIES A — Biomet Orthopedics, Inc. · Class II
- EXULT Knee Replacement System — Corentec Co., Ltd · Class II
- Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
- Sombrero Patella Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class II
- Gender Solutions® Natural-Knee® — Zimmer, Inc. · Class I
Cleared under the same submission
K160025 also covers:
- iTotal® CR Tibial Keel Punch Tip — Conformis, Inc.
- iTotal® CR Tibial Keel Punch Tip — Conformis, Inc.
- iTotal® CR Tibial Keel Punch Tip — Conformis, Inc.
- iTotal® CR Tibial Tray Impactor Tip — Conformis, Inc.
- iTotal® Impactor Head — Conformis, Inc.
- iTotal® Impactor Head — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
- iTotal® PS — Conformis, Inc.
- iTotal® PS — 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 7f3971c9-5ba8-4eee-a22e-e890b9b72b18 36 fields · synced May 31, 2026