Identity
- Trade Name
- JOURNEY FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Device Name
- JOURNEY PATELLA REAMER SHAFT FDA UDI
- Model / Reference
- 74019305 FDA UDI
- Description
- JOURNEY PATELLA REAMER SHAFT FDA UDI
Identifiers
- Catalog Number
- 74019305 FDA UDI
- Primary DI / UDI-DI
- 03596010557322 FDA UDI
- 510(k) Number
- K121393 FDA UDI
- FDA Product Code
- HRY FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-resection orthopaedic reamer, reusable
Journey by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-resection orthopaedic reamer, reusable.
- InSitu Hip System — Nextstep Arthropedix · Class I
- Tornier Perform — TORNIER, INC. · Class I
- Arcos® STS™ Modular Revision System — Biomet Orthopedics, Inc. · Class II
- Vanguard® — Biomet Orthopedics, Inc. · Class I
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- LINK Instruments - Drills, reamers and saw blades — WALDEMAR LINK GmbH & Co. KG · Class I
- APEX Knee System — OMNIlife science, Inc. · Class I
Cleared under the same submission
K121393 also covers:
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GII — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- JOURNEY — Smith & Nephew, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 8a802bbf-b007-4c4a-9b0a-ec400e8d7827 36 fields · synced Jun 8, 2026