Identity
- Trade Name
- Optimotion Blue CR HCCR Total Knee System FDA UDI
- Generic Name
- Cruciate-retaining total knee prosthesis FDA UDI
- Device Name
- CR Tibial Insert, UHMWPE + Vitamin E, Size 7, Thickness 13mm, Left FDA UDI
- Model / Reference
- 1014-P-0713-01 FDA UDI
- Description
- CR Tibial Insert, UHMWPE + Vitamin E, Size 7, Thickness 13mm, Left FDA UDI
Identifiers
- Primary DI / UDI-DI
- B6961014P0713010 FDA UDI
- 510(k) Number
- K191084 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDIOIY FDA UDI
- GMDN Term
- Cruciate-retaining total knee prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 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
Category: Cruciate-retaining total knee prosthesis
Optimotion Blue CR HCCR Total Knee System by Optimotion Implants, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cruciate-retaining total knee prosthesis.
- Arthrex® — Arthrex, Inc. · Class II
- Columbus® UC — AESCULAP, INC. · Class II
- UKNEE Tibial insert, plained — UNITED ORTHOPEDIC CORP. · Class II
- B-P TOTAL KNEE SYSTEM — ENDOTEC, INC. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Cleared under the same submission
K191084 also covers:
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC
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
- Optimotion Implants, Llc
Sources (1)
- FDA UDI 32052c04-e857-464d-a95e-f2229b5e121d 35 fields · synced May 30, 2026