# K170282: Smith & Nephew VISIONAIRE Adaptive Guides

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: May 22, 2017 after 112 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: 2 generations back to K082358 (2008). 2 ancestors in all.
7 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)
- K130708: Smith & Nephew Patient Matched Cutting Blocks, Smith & Nephew, Inc. (2013) Summary page 4.

## Most influential descendants
- K172336: Smith & Nephew Patient Matched Cutting Blocks (2018), 6 descendants of its own
- K183010: Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks (2018), 5 descendants of its own
- K200826: Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks (2020), 4 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K170282
Methodology: https://510kreport.com/methodology