Smith & Nephew, Inc. Journey Select Knee System
FDA 510(k) K093056 · Smith & Nephew, Inc.
510(k) numberK093056
Submission
- Device name
- Smith & Nephew, Inc. Journey Select Knee System
- Applicant
- Smith & Nephew, Inc.
Memphis, TN, US - Received
- September 30, 2009
- Decision date
- December 15, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPJ – Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.
Other 510(k)s with product code NPJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150307 | RESTORIS Multicompartmental Knee SystemNPJ · Special | Mako Surgical Corp. | 03/10/2015SE |
| K133039 | Restoris Multicompartmental Knee SystemNPJ · Special | Mako Surgical Corporation | 12/10/2013SE |
| K093513 | Iduo Bicompartmental Knee Repair SystemNPJ · Special | Conformis, Inc. | 12/16/2009SE |
| K090763 | Restoris Multicompartmental Knee (MCK) SystemNPJ · Traditional | Mako Surgical Corporation | 06/17/2009SE |
| K070849 | Depuy GCK Femoral and Tibial ComponentsNPJ · Traditional | DePuy Orthopaedics, Inc. | 06/26/2007SE |
| K061648 | Depuy Graduated Compartmental Knee (GCK)NPJ · Traditional | DePuy Orthopaedics, Inc. | 09/11/2006SE |
| K061569 | Smith & Nephew Competitor Deuce Femoral ComponentsNPJ · Special | Smith & Nephew, Inc. | 07/06/2006SE |
| K053488 | Conformis Bicompartmental Knee Repair SystemNPJ · Traditional | Conformis, Inc. | 03/09/2006SE |
| K052917 | Stryker Compartmental Knee SystemNPJ · Traditional | Howmedica Osteonics Corp. | 12/27/2005SE |
| K052265 | Smith & Nephew Competitor Duo Knee FemoralNPJ · Abbreviated | Smith & Nephew, Inc. | 12/27/2005SE |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 Smith & Nephew, Inc. Journey Select Knee System cleared by the FDA?
Smith & Nephew, Inc. Journey Select Knee System (K093056) received a 510(k) decision of Substantially Equivalent on December 15, 2009, 76 days after the submission was received.
What is the product code of K093056?
The FDA product code is NPJ – Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.