510(k) · Cleared
ClearedVISIONAIRE UK Patient Matched Cutting Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Sep 16, 2021 as substantially equivalent to K173970 (Materialise NV, 2018) and 1 other predicate after a 125-day review. Its family tree reaches back 11 generations to 1993. 3 later devices descend from it.
- Decided
- Sep 16, 2021
- Review
- 125 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K924630 (1993). 28 ancestors in all, the oldest K880155 (1988). 3 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 7 generations between
- 3 generations backK162273 Materialise TKA Guide SystemMaterialise NV · 2016
- 2 generations backK172650 Materialise PKA Guide SystemMaterialise NV · 2017
- 1 generation backK173970 Materialise PKA Guide SystemMaterialise NV · 2018
- This deviceK211512 VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK240113 CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK242272 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK250921 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 10 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 9 generations backK033849 Simplant SystemMaterialise NV · 2004
- 8 generations backK073449 SurgicaseMaterialise NV · 2008
- 7 generations backK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
- 6 generations backK121640 Zimmer Patient Specific Instruments SystemMaterialise NV · 2012 · Recalled
- 5 generations backK133162 Zimmer Patient Specific Instruments System, Zimmer Patient Specific…Materialise NV · 2014
- 4 generations backK150928 Materialise TKA Guide System, Materialise TKA Planner, Materialise…Materialise NV · 2015
- 3 generations backK162273 Materialise TKA Guide SystemMaterialise NV · 2016
- 2 generations backK172650 Materialise PKA Guide SystemMaterialise NV · 2017
- 1 generation backK173970 Materialise PKA Guide SystemMaterialise NV · 2018
- This deviceK211512 VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024 · cites it directly2descendants
- K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024 · 2 generations on1descendant
- K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −10 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −9 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −8 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −7 | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | 4 |
| −6 | K121640 | Zimmer Patient Specific Instruments System | Materialise NV | 2012 | 1 |
| −5 | K133162 | Zimmer Patient Specific Instruments System, Zimmer Patient Specific… | Materialise NV | 2014 | — |
| −4 | K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | Materialise NV | 2015 | — |
| −3 | K162273 | Materialise TKA Guide System | Materialise NV | 2016 | — |
| −2 | K172650 | Materialise PKA Guide System | Materialise NV | 2017 | — |
| −1 | K173970 | Materialise PKA Guide System | Materialise NV | 2018 | — |
| 0 (this device) | K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021 | — |
| +1 | K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024 | — |
| +2 | K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2024 | — |
| +3 | K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 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 |
|---|---|---|---|
| * | K173970 | Materialise PKA Guide SystemSummary page 6…lymer semi-constrained cemented prosthesis Predicate Device: Primary Predicate: Materialise PKA Guide System - K173970 (S.E. 7/6/2018) HSX, OOG Secondary Predicate: VISIONAIRE Patient… | 2018 |
| * | K200826 | Smith&Nephew VISIONAIRE Patient Matched Cutting BlocksSummary page 6…3970 (S.E. 7/6/2018) HSX, OOG Secondary Predicate: VISIONAIRE Patient Matched Cutting Blocks - K200826 (S.E. 4/24/2020) JWH, MBH, OOG Reference Device: VISIO… | 2020 |
| † | K170282 | Smith & Nephew VISIONAIRE Adaptive Guides | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240113 | CORIOGRAPH Knee Pre-Op Plan | 2024 | 2 |
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 3 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 28 ancestors have a recall of any class.
- Of its descendants, K240113 (Smith & Nephew, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K173970.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Smith & Nephew's VISIONAIRE UK Patient Matched Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of 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 UK Patient Matched Cutting Guides are…
Read the full statement (110 words)
Smith & Nephew's VISIONAIRE UK Patient Matched Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of 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 UK Patient Matched Cutting Guides are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:
- JOURNEY II Unicompartmental Knee (JOURNEY II UK) System
The Smith & Nephew VISIONAIRE UK Patient Matched Cutting 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/K211512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211512: VISIONAIRE UK Patient Matched Cutting Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211512
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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