Identity
- Trade Name
- Universal Cone FDA UDI
- Generic Name
- Knee arthroplasty wedge FDA UDI
- Device Name
- Cone, Size 4, 18 degree FDA UDI
- Model / Reference
- 6800.04.018 FDA UDI
- Description
- Cone, Size 4, 18 degree FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810094700508 FDA UDI
- 510(k) Number
- K230537 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDIOIY FDA UDI
- GMDN Term
- Knee arthroplasty wedge 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
Radiation Sterilization FDA UDI
Category: Knee arthroplasty wedge
Universal Cone by Total Joint Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee arthroplasty wedge.
- NexGen® — Zimmer, Inc. · Class II
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- 3DMetal Diaphyseal Femoral Cones — Medacta International · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- Unity Total Knee System — CORIN LTD · Class II
Cleared under the same submission
K230537 also covers:
- Klassic Femoral Augment Screw, Distal — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Femoral Augment, Distal — TOTAL JOINT ORTHOPEDICS, 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
- Total Joint Orthopedics, Inc.
Sources (1)
- FDA UDI 22761379-0cf6-4612-97d0-53ebf6bb7a6a 37 fields · synced May 31, 2026