510(k) · Cleared
ClearedSmith & Nephew VISIONAIRE Adaptive Guides
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 May 22, 2017 as substantially equivalent to K130708 (Smith & Nephew, Inc., 2013) after a 112-day review. Its family tree reaches back 2 generations to 2008. 7 later devices descend from it.
- Decided
- May 22, 2017
- Review
- 112 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082358 (2008). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK082358 Smith & Nephew, Inc. Patient Matched TechnologySmith & Nephew, Inc. · 2008
- 1 generation backK130708 Smith & Nephew Patient Matched Cutting BlocksSmith & Nephew, Inc. · 2013
- This deviceK170282 Smith & Nephew VISIONAIRE Adaptive GuidesSmith & Nephew, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK172336 Smith & Nephew Patient Matched Cutting BlocksSmith & Nephew, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK183010 Smith & Nephew VISIONAIRE Patient Matched Cutting BlocksSmith & Nephew, Inc. · 2018
- Descendant · 3 generations on · 4 of its ownK200826 Smith&Nephew VISIONAIRE Patient Matched Cutting BlocksSmith & Nephew, Inc. · 2020
- Descendant · 4 generations on · 3 of its ownK211512 VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc. · 2021
- Descendant · 5 generations on · 2 of its ownK240113 CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K172336Smith & Nephew Patient Matched Cutting BlocksSmith & Nephew, Inc. · 2018 · cites it directly6descendants
- K183010Smith & Nephew VISIONAIRE Patient Matched Cutting BlocksSmith & Nephew, Inc. · 2018 · 2 generations on5descendants
- K200826Smith&Nephew VISIONAIRE Patient Matched Cutting BlocksSmith & Nephew, Inc. · 2020 · 3 generations on4descendants
- K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc. · 2021 · 4 generations on3descendants
- K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082358 | Smith & Nephew, Inc. Patient Matched Technology | Smith & Nephew, Inc. | 2008 | — |
| −1 | K130708 | Smith & Nephew Patient Matched Cutting Blocks | Smith & Nephew, Inc. | 2013 | — |
| 0 (this device) | K170282 | Smith & Nephew VISIONAIRE Adaptive Guides | Smith & Nephew, Inc. | 2017 | — |
| +1 | K172336 | Smith & Nephew Patient Matched Cutting Blocks | Smith & Nephew, Inc. | 2018 | — |
| +2 | K183010 | Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks | Smith & Nephew, Inc. | 2018 | — |
| +3 | K200826 | Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks | Smith & Nephew, Inc. | 2020 | — |
| +4 | K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021 | — |
| +5 | K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K130708 | Smith & Nephew Patient Matched Cutting BlocksSummary page 4…notification are surgical alignment instruments to evaluate guide position. Patient Matched Cutting Blocks were previously cleared for market via premarket notification K130708. Intended Use Smith & Nephew's VISIONAIRE Adaptive Guides are intended to be used as patient-specific surgical instrumentation t… | 2013 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172336 | Smith & Nephew Patient Matched Cutting Blocks | 2018 | 6 |
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 9 years and passes through 1 company; a new generation was cleared every 5.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K172336 (Smith & Nephew, Inc., 2018) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K130708.
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. 2017, 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 Adaptive Guides 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 Adaptive Guides are intended for use with the…
Read the full statement (112 words)
Smith & Nephew's VISIONAIRE Adaptive Guides 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 Adaptive Guides 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 Adaptive Guides are intended for single use only.
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/K170282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170282: Smith & Nephew VISIONAIRE Adaptive Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170282
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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