510(k) · Cleared
ClearedSmith & Nephew, Inc. Journey Select Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 15, 2009 as substantially equivalent to K052917 (Howmedica Osteonics Corp., 2005) and 4 other predicates after a 76-day review. Its family tree reaches back 5 generations to 1994. 9 later devices descend from it.
- Decided
- Dec 15, 2009
- Review
- 76 days
- Class
- Class II
- Product code
- NPJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K943462 (1994). 15 ancestors in all, the oldest K910968 (1991). 9 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 4 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 3 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 2 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 1 generation backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- This deviceK093056 Smith & Nephew, Inc. Journey Select Knee SystemSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- Descendant · 2 generations on · 7 of its ownK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK191211 JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K160738ZUK Select Knee SystemSmith & Nephew, Inc. · 2016 · cites it directly8descendants
- K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 2 generations on7descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · 3 generations on3descendants
- K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 2 generations on1descendant
- K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −4 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −3 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −2 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −1 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| 0 (this device) | K093056 | Smith & Nephew, Inc. Journey Select Knee System | Smith & Nephew, Inc. | 2009 | — |
| +1 | K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016 | — |
| +2 | K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | 3 |
| +3 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +2 | K191211 | JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | — |
| +4 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NPJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052917 | Stryker Compartmental Knee SystemSummary page 2…nt. The Journey Select Knee System is substantially equivalent to the following compartmental knee systems: * Howmedica Osteonics Stryker" Compartmental Knee System, K052917 * Howmedica Osteonics Stryker'o Compartmental Knee System Line Extension, K082567 a DePuy Orthopaedics Graduated Compartm… | 2005 |
| * | K082567 | Stryker Compartmental Knee System Line ExtensionSummary page 2…tmental knee systems: * Howmedica Osteonics Stryker" Compartmental Knee System, K052917 * Howmedica Osteonics Stryker'o Compartmental Knee System Line Extension, K082567 a DePuy Orthopaedics Graduated Compartmental Knee (GCK), K061648 *DePuy GCK Femoral and Tibial Components, K070849… | 2008 |
| * | K061648 | Depuy Graduated Compartmental Knee (GCK)Summary page 2…l Knee System, K052917 * Howmedica Osteonics Stryker'o Compartmental Knee System Line Extension, K082567 a DePuy Orthopaedics Graduated Compartmental Knee (GCK), K061648 *DePuy GCK Femoral and Tibial Components, K070849 *DePuy GCK Femoral and Tibial Components, K070267… | 2006 |
| * | K070849 | Depuy GCK Femoral and Tibial ComponentsSummary page 2…o Compartmental Knee System Line Extension, K082567 a DePuy Orthopaedics Graduated Compartmental Knee (GCK), K061648 *DePuy GCK Femoral and Tibial Components, K070849 *DePuy GCK Femoral and Tibial Components, K070267 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2007 |
| * | K070267 | Depuy GCK Tibial ComponentsSummary page 2…DePuy Orthopaedics Graduated Compartmental Knee (GCK), K061648 *DePuy GCK Femoral and Tibial Components, K070849 *DePuy GCK Femoral and Tibial Components, K070267 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2007 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160738 | ZUK Select Knee System | 2016 | 8 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 15 ancestors have a recall of any class.
- Of its descendants, K160738 (Smith & Nephew, Inc., 2016) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K052917.
How does its category compare?
All NPJ devicesNPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NPJ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NPJ
76in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPJ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPJ
47in 2025
MAUDE reports naming product code NPJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 3 | 76 | 0 | 3 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 0 | — | 0 | 72 |
| 2013 | 1 | — | 0 | 98 |
| 2014 | 0 | — | 0 | 75 |
| 2015 | 1 | — | 3 | 55 |
| 2016 | 0 | — | 1 | 93 |
| 2017 | 0 | — | 0 | 150 |
| 2018 | 0 | — | 0 | 141 |
| 2019 | 0 | — | 0 | 91 |
| 2020 | 0 | — | 0 | 65 |
| 2021 | 0 | — | 0 | 51 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 52 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 0 | 47 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Smith & Nephew, Inc. Journey Select Knee System is intended to be used for those patients whereby conditions exist that may not be solely addressed by a device that treats a single, compartment. The Journey Select Knee System is intended to replace the patellofemoral and either the medial or lateral condyle of the knee joint in patients where there is evidence of sufficient sound bone to seat and support the components. Indications include 1.…
Read the full statement (144 words)
The Smith & Nephew, Inc. Journey Select Knee System is intended to be used for those patients whereby conditions exist that may not be solely addressed by a device that treats a single, compartment. The Journey Select Knee System is intended to replace the patellofemoral and either the medial or lateral condyle of the knee joint in patients where there is evidence of sufficient sound bone to seat and support the components. Indications include
1. Post-traumnatic arthritis;
2. Degenerative arthritis; and
3. Failed osteotomies and unicompartmental replacement.
These indications will be used for the Journey Select Knee System, whereby a single condyle and patellofemoral regions of the knee have been affected by one or more of these conditions. The implant devices of the Smith & Nephew. Inc. Journey Select Knee System are single use only and are intended for implantation only with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093056 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093056: Smith & Nephew, Inc. Journey Select Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093056
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026