510(k) · Cleared
ClearedJourney II CR 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 Aug 13, 2012 as substantially equivalent to K111711 (Smith & Nephew, Inc., 2011) and 1 other predicate after a 90-day review. Its family tree reaches back 6 generations to 1995. 37 later devices descend from it.
- Decided
- Aug 13, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K951987 (1995). 21 ancestors in all, the oldest K933787 (1994). 37 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 5 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 4 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- 2 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- 1 generation backK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- This deviceK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 18 of its ownK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
- Descendant · cites it directly · 12 of its ownK141471 Journey II XR Knee SystemSmith & Nephew, Inc. · 2014
- Descendant · 2 generations on · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
- Descendant · 2 generations on · 8 of its ownK152315 JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015
- Descendant · 2 generations on · 8 of its ownK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K141934Physica KR Knee SystemLima Corporate S.P.A. · 2015 · cites it directly18descendants
- K141471Journey II XR Knee SystemSmith & Nephew, Inc. · 2014 · cites it directly12descendants
- K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · 2 generations on8descendants
- K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015 · 2 generations on8descendants
- K151266Physica CR Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −5 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −4 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −3 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| −2 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| −1 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| 0 (this device) | K121443 | Journey II CR Knee System | Smith & Nephew, Inc. | 2012 | — |
| +1 | K141934 | Physica KR Knee System | Lima Corporate S.P.A. | 2015 | — |
| +1 | K141471 | Journey II XR Knee System | Smith & Nephew, Inc. | 2014 | — |
| +2 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019 | — |
| +2 | K152315 | JOURNEY II Uni Tibial Base and Insert | Smith & Nephew, Inc. | 2015 | — |
| +2 | K151266 | Physica CR Knee System | Lima Corporate S.P.A. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K111711 | Journey II BCS Knee SystemSummary page 2…System Reviewed Sytmsystem ___________ 510(k) Number Subject 510(k) K111711 K101499 Manufacturer Smith & Nephew, Inc Smith & Nephew, Inc Smith & Ne… | 2011 |
| * | K101499 | Journey CR Knee SystemSummary page 2…Sytmsystem ___________ 510(k) Number Subject 510(k) K111711 K101499 Manufacturer Smith & Nephew, Inc Smith & Nephew, Inc Smith & Nephew, Inc Similar Indications… | 2010 |
What descends from it? (37)
See all 377 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141934 | Physica KR Knee System | 2015 | 18 |
| K141471 | Journey II XR Knee System | 2014 | 12 |
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and… | 2023 | 3 |
| K200407 | LEGION Inserts with JRNY Lock | 2020 | 2 |
| K211671 | Journey II Mid-Level Tibial Inserts | 2021 | 1 |
| K261462 | LANDMARK Total Knee System | 2026 | 0 |
| K123692 | Pipeline Knee System | 2013 | 0 |
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 17 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 13 of the 21 ancestors have a recall of any class.
- Of its descendants, K141934 (Lima Corporate S.P.A., 2015) has gone furthest, with 18 descendants of its own.
- 6 other devices also cite its predicate K111711.
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. 2012, 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; failed osteotomies, unicompartmental 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 incompetent and the collateral ligaments remain intact.
The Journey 11Total Knee system 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/K121443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121443: Journey II CR 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/K121443
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