Identity
- Trade Name
- iDuo FDA UDI
- Generic Name
- Bicompartmental knee prosthesis FDA UDI
- Device Name
- IDUO–IPOLY–IMPLANT KIT–LEFT or right MEDIAL or lateral FDA UDI
- Model / Reference
- BKA-111-111102 FDA UDI
- Description
- IDUO–IPOLY–IMPLANT KIT–LEFT or right MEDIAL or lateral FDA UDI
Identifiers
- Catalog Number
- BKA-111-1111 FDA UDI
- Primary DI / UDI-DI
- M572BKA1111111021 FDA UDI
- 510(k) Number
- K093513 FDA UDI
- FDA Product Code
- NPJ FDA UDI
- GMDN Term
- Bicompartmental knee 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
Category: Bicompartmental knee prosthesis
iDuo by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bicompartmental knee prosthesis.
- LEGION — Smith & Nephew, Inc. · Class II
- FREEDOM STEMMED — MAXX ORTHOPEDICS INC. · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- FREEDOM STEMMED — MAXX ORTHOPEDICS INC. · Class II
- FREEDOM STEMMED — MAXX ORTHOPEDICS INC. · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- FREEDOM STEMMED — MAXX ORTHOPEDICS INC. · Class II
- LEGION — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K093513 also covers:
- iDuo® Patella — 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 4a3fefdf-d258-4f76-bcab-7955a5425aac 36 fields · synced Jun 1, 2026