Identity
- Trade Name
- iDuo® Patella FDA UDI
- Generic Name
- Polyethylene patella prosthesis FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- PAB011411002 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- PAB0114110 FDA UDI
- Primary DI / UDI-DI
- M572PAB0114110021 FDA UDI
- 510(k) Number
- K093513 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Polyethylene patella 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 41 Millimeter FDA UDI
Category: Polyethylene patella prosthesis
iDuo® Patella by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene patella prosthesis.
- VANGUARD KNEE SYSTEM — Biomet Orthopedics, Inc. · Class II
- Duracon — Howmedica Osteonics Corp. · Class II
- PERSONA® — Zimmer, Inc. · Class II
- S-ROM NOILES — DEPUY (IRELAND) · Class II
- LOSPA Total Knee System — Corentec Co., Ltd · Class II
- ADVANCE® — MicroPort Orthopedics Inc. · Class II
- Unity Total Knee System — CORIN LTD · Class II
- Proven Gen-Flex PS Knee System — GLOBUS MEDICAL, INC. · Class II
Cleared under the same submission
K093513 also covers:
- iDuo — Conformis, Inc.
- iDuo® Patella — Conformis, Inc.
- iDuo® Patella — Conformis, Inc.
- iDuo® Tibial Kit — Conformis, Inc.
- iDuo® iPoly™ Insert Kit — Conformis, Inc.
- iDuo® iPoly™ Insert Kit — Conformis, Inc.
- iDuo® iPoly™ Insert Kit — Conformis, Inc.
- iDuo® iPoly™ Insert Kit — Conformis, Inc.
- iDuo® iPoly™ Insert Kit — Conformis, Inc.
- iDuo® iPoly™ Insert Kit — Conformis, Inc.
- iDuo® iPoly™ Insert Kit — Conformis, Inc.
- iDuo® 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 f95d5aeb-0a50-41ba-8996-53095fdc504d 37 fields · synced May 30, 2026