JOURNEY II Uni Tibial Base and Insert
FDA 510(k) K152315 · Smith & Nephew, Inc.
510(k) numberK152315
Submission
- Device name
- JOURNEY II Uni Tibial Base and Insert
- Applicant
- Smith & Nephew, Inc.
Cordova, TN, US - Received
- August 17, 2015
- Decision date
- October 28, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3520
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HSX
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|---|---|---|---|
| K261609 | Freedom Partial Knee SystemHSX · Traditional | Maxx Orthopedics, Inc. | 08/04/2026SE |
| K260796 | Tahoe Unicondylar Knee System with TiNbN OvercoatHSX · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 04/02/2026SE |
| K251771 | Cambridge Partial KneeHSX · Traditional | Signature Orthopaedics Pty, Ltd. | 12/16/2025SE |
| K251834 | Persona Partial KneeHSX · Traditional | Zimmer Biomet | 08/15/2025SE |
| K251618 | MOTO Partial Knee System ExtensionHSX · Traditional | Medacta International S.A. | 07/24/2025SE |
| K251453 | Arthrex iBalance Partial Knee SystemHSX · Traditional | Arthrex, Inc. | 07/01/2025SE |
| K241260 | ACTIFY Unicondylar Knee SystemHSX · Traditional | Globus Medical, Inc. | 12/06/2024SE |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK)HSX · Traditional | Smith & Nephew, Inc. | 10/30/2024SE |
| K242746 | OvertureTi Knee Resurfacing SystemTMHSX · Special | Overture Orthopaedics | 10/07/2024SE |
| K232114 | TRIBRID® Unicompartmental Knee SystemHSX · Traditional | Kyocera Medical Technologies, Inc. | 04/04/2024SE |
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| 510(k) | Device | Decision |
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| K261462 | LANDMARK Total Knee SystemMBH · Traditional | 09/08/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | 07/09/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | 04/06/2026SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | 10/29/2025SE |
| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | 10/03/2025SE |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
| K250677 | LEGION Total Knee SystemJWH · Special | 04/02/2025SE |
| K250571 | CATALYSTEM Femoral StemsLZO · Special | 03/28/2025SE |
| K241666 | EVOS Pelvic and Acetabular SystemHRS · Traditional | 02/19/2025SE |
Questions and answers
When was JOURNEY II Uni Tibial Base and Insert cleared by the FDA?
JOURNEY II Uni Tibial Base and Insert (K152315) received a 510(k) decision of Substantially Equivalent on October 28, 2015, 72 days after the submission was received.
What is the product code of K152315?
The FDA product code is HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3520.