510(k) · Cleared
ClearedCemented Tibia Baseplate no Taper with JRNY Lock
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 Mar 30, 2023 as substantially equivalent to K142807 (Smith & Nephew, Inc., 2014) and 1 other predicate after a 30-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Mar 30, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K951987 (1995). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 7 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 6 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- 4 generations backK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
- 3 generations backK093746 Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc. · 2010
- 2 generations backK112941 Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized…Smith & Nephew, Inc. · 2011 · Recalled
- 1 generation backK142807 ANTHEM PS Total Knee SystemSmith & Nephew, Inc. · 2014
- This deviceK230555 Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −7 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −6 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −5 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071071 | Crosslinked Polyethylene Articular Inserts | Smith & Nephew, Inc. | 2007 | 5 |
| −3 | K093746 | Verilast Wear Claims for the Legion Primary Knee System | Smith & Nephew, Inc. | 2010 | — |
| −2 | K112941 | Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral… | Smith & Nephew, Inc. | 2011 | 3 |
| −1 | K142807 | ANTHEM PS Total Knee System | Smith & Nephew, Inc. | 2014 | — |
| 0 (this device) | K230555 | Cemented Tibia Baseplate no Taper with JRNY Lock | Smith & Nephew, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 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 |
|---|---|---|---|
| * | K142807 | ANTHEM PS Total Knee SystemSummary page 4…polymer/metal/polymer semi-constrained cemented prothesis Predicate Device: Primary Predicate K142807 ANTHEM PS Total Knee System (S.E. 12/22/2014) JWH… | 2014 |
| * | K111711 | Journey II BCS Knee SystemSummary page 4…PS Total Knee System (S.E. 12/22/2014) JWH Secondary Predicate K111711 JOURNEY II BCS Knee System (S.E. 09/16/2011) JWH… | 2011 |
| † | K042515 | Smith & Nephew, Inc. High Performance Knee | 2005 |
| † | K220896 | Legion Inserts with JRNY Lock | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 9 of the 16 ancestors have a recall of any class.
- 3 other devices also cite its predicate K142807.
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. 2023, 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 Smith & Nephew Cemented Tibia Baseplate no Taper with JRNY Lock are indicated for use with cement only and are single use devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230555: Cemented Tibia Baseplate no Taper with JRNY Lock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230555
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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