Identity
- Trade Name
- DJO SURGICAL FDA UDI
- Generic Name
- Cruciate-retaining total knee prosthesis FDA UDI
- Device Name
- BASEPLATE, TIBIAL, STEMMED, 3D, SIZE4L NONPOROUS FDA UDI
- Model / Reference
- 333-01-104 FDA UDI
- Description
- BASEPLATE, TIBIAL, STEMMED, 3D, SIZE4L NONPOROUS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888912115391 FDA UDI
- 510(k) Number
- K020114 FDA UDI
- FDA Product Code
- MBH FDA UDIJWH FDA UDI
- GMDN Term
- Cruciate-retaining total knee prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3565 FDA UDI888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Uncoated knee tibia prosthesis, metallicCruciate-retaining total knee prosthesis
Djo Surgical by Encore Medical, L.p. — 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
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC · Class II
- UKNEE Tibial insert, plained — UNITED ORTHOPEDIC CORP. · Class II
- B-P TOTAL KNEE SYSTEM — ENDOTEC, INC. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- STERIZO Total Knee System — CPM Medical Consultants, LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
Cleared under the same submission
K020114 also covers:
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
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
- Encore Medical, L.p.
Sources (1)
- FDA UDI e1b0246e-4712-4d1f-88a2-447e853ae368 34 fields · synced Jun 8, 2026