510(k) · Cleared
ClearedSmith&Nephew VISIONAIRE Patient Matched Cutting Blocks
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 Apr 24, 2020 as substantially equivalent to K183010 (Smith & Nephew, Inc., 2018) after a 25-day review. Its family tree reaches back 5 generations to 2008. 4 later devices descend from it.
- Decided
- Apr 24, 2020
- Review
- 25 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K082358 (2008). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK082358 Smith & Nephew, Inc. Patient Matched TechnologySmith & Nephew, Inc. · 2008
- 4 generations backK130708 Smith & Nephew Patient Matched Cutting BlocksSmith & Nephew, Inc. · 2013
- 3 generations backK170282 Smith & Nephew VISIONAIRE Adaptive GuidesSmith & Nephew, Inc. · 2017
- 2 generations backK172336 Smith & Nephew Patient Matched Cutting BlocksSmith & Nephew, Inc. · 2018
- 1 generation backK183010 Smith & Nephew VISIONAIRE Patient Matched Cutting BlocksSmith & Nephew, Inc. · 2018
- This deviceK200826 Smith&Nephew VISIONAIRE Patient Matched Cutting BlocksSmith & Nephew, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK211512 VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK240113 CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK242272 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK250921 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc. · 2021 · cites it directly3descendants
- K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024 · 2 generations on2descendants
- K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024 · 3 generations on1descendant
- K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K082358 | Smith & Nephew, Inc. Patient Matched Technology | Smith & Nephew, Inc. | 2008 | — |
| −4 | K130708 | Smith & Nephew Patient Matched Cutting Blocks | Smith & Nephew, Inc. | 2013 | — |
| −3 | K170282 | Smith & Nephew VISIONAIRE Adaptive Guides | Smith & Nephew, Inc. | 2017 | — |
| −2 | K172336 | Smith & Nephew Patient Matched Cutting Blocks | Smith & Nephew, Inc. | 2018 | — |
| −1 | K183010 | Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks | Smith & Nephew, Inc. | 2018 | — |
| 0 (this device) | K200826 | Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks | Smith & Nephew, Inc. | 2020 | — |
| +1 | K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021 | — |
| +2 | K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024 | — |
| +3 | K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2024 | — |
| +4 | K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K183010 | Smith & Nephew VISIONAIRE Patient Matched Cutting BlocksSummary page 4…e design and manufacture of the VISIONAIRE Patient Matched Cutting Blocks. Patient Matched Cutting Blocks were previously cleared for market via premarket notifications- K183010. The blocks are designed utilizing the VISIONAIRE Patient Matched Technology software components and patient imaging data (MRI, X… | 2018 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211512 | VISIONAIRE UK Patient Matched Cutting Guides | 2021 | 3 |
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 12 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K211512 (Smith & Nephew, Inc., 2021) has gone furthest, with 3 descendants of its own.
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. 2020, 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?
Smith & Nephew's VISIONAIRE Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are…
Read the full statement (118 words)
Smith & Nephew's VISIONAIRE Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:
- Genesis II Knee System
- Legion Knee System
- Journey BCS Knee System
- Journey II Knee System
The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200826 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200826: Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200826
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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