# K200826: Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 24, 2020 after 25 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K082358 (2008). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183010: Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks, Smith & Nephew, Inc. (2018) Summary page 4.

## Most influential descendants
- K211512: VISIONAIRE UK Patient Matched Cutting Guides (2021), 3 descendants of its own
- K240113: CORIOGRAPH Knee Pre-Op Plan (2024), 2 descendants of its own
- K242272: CORIOGRAPH Pre-Op Planning and Modeling Services (2024), 1 descendant of its own
- K250921: CORIOGRAPH Pre-Op Planning and Modeling Services (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K200826
Methodology: https://510kreport.com/methodology