# K130708: Smith & Nephew Patient Matched Cutting Blocks

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 11, 2013 after 271 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: 1 generation back to K082358 (2008). 1 ancestor in all.
8 later devices descend from it; 2 cite 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)
- K082358: Smith & Nephew, Inc. Patient Matched Technology, Smith & Nephew, Inc. (2008) Summary page 1.

## Most influential descendants
- K170282: Smith & Nephew VISIONAIRE Adaptive Guides (2017), 7 descendants of its own
- 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

## Indications for use
Smith & Nephew’s 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 Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. knee systems and their cleared indications for use: e Genesis Il Knee System e Legion Knee System e Journey BCS Knee System o Journey II Knee System The Patient Matched Cutting Blocks are intended for single use only.

Source page: https://510kreport.com/device/K130708
Methodology: https://510kreport.com/methodology