510(k) · Cleared
ClearedJourney BCS Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 29, 2009 as substantially equivalent to K042515 (Smith & Nephew, Inc., 2005) after a 173-day review. Its family tree reaches back 2 generations to 1995. 41 later devices descend from it.
- Decided
- Sep 29, 2009
- Review
- 173 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951987 (1995). 4 ancestors in all. 41 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 1 generation backK042515 Smith & Nephew, Inc. High Performance KneeSmith & Nephew, Inc. · 2005 · Recalled
- This deviceK091014 Journey BCS Knee SystemSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 40 of its ownK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 37 of its ownK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- Descendant · 3 generations on · 18 of its ownK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
- Descendant · 3 generations on · 12 of its ownK141471 Journey II XR Knee SystemSmith & Nephew, Inc. · 2014
- Descendant · 4 generations on · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K111711Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · cites it directly40descendants
- K121443Journey II CR Knee SystemSmith & Nephew, Inc. · 2012 · 2 generations on37descendants
- K141934Physica KR Knee SystemLima Corporate S.P.A. · 2015 · 3 generations on18descendants
- K141471Journey II XR Knee SystemSmith & Nephew, Inc. · 2014 · 3 generations on12descendants
- K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −1 | K042515 | Smith & Nephew, Inc. High Performance Knee | Smith & Nephew, Inc. | 2005 | 3 |
| 0 (this device) | K091014 | Journey BCS Knee System | Smith & Nephew, Inc. | 2009 | — |
| +1 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| +2 | K121443 | Journey II CR Knee System | Smith & Nephew, Inc. | 2012 | — |
| +3 | K141934 | Physica KR Knee System | Lima Corporate S.P.A. | 2015 | — |
| +3 | K141471 | Journey II XR Knee System | Smith & Nephew, Inc. | 2014 | — |
| +4 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K042515 | Smith & Nephew, Inc. High Performance KneeSummary page 1…ass 11 Device Product Code: JVVH Device Description This premarket notification seeks only to add kinematics claims for the existing Journey BCS Knee System cleared via K042515. No new total knee components being introduced as a result of this premarket notification. Intended Use Total knee components ar… | 2005 |
| † | K053514 | Triathlon Total Knee System | 2006 |
What descends from it? (41)
See all 411 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111711 | Journey II BCS Knee System | 2011 | 40 |
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 14 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K111711 (Smith & Nephew, Inc., 2011) has gone furthest, with 40 descendants of its own.
- 11 other devices also cite its predicate K042515.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, 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 · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis,
osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are
compatible with an adequate long-term result; failed osteotomies, unicomparimental replacement,
or total knee replacement. Posterior stabilized knee systems are designed for use in patients in
primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or
incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. Journey BCS Knee
components are indicated for use only with cement and are single use devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091014: Journey BCS Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091014
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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