# K162273: Materialise TKA Guide System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Nov 7, 2016 after 87 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: 8 generations back to K924630 (1993). 12 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150928: Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides, Materialise NV (2015) Summary page 5.

## Most influential descendants
- K173445: Materialise TKA Guide System (2018), 9 descendants of its own
- K172650: Materialise PKA Guide System (2017), 6 descendants of its own
- K173970: Materialise PKA Guide System (2018), 5 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
The Materialise TKA Guide System is intended to be used as a surgical instrument 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 Materialise TKA Guide System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Trabecular Metal™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Consensus Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR and Omni Apex PS total knee prostheses during total knee arthroplasty surgical procedures. The Materialise TKA Guides are intended for single use only.

Source page: https://510kreport.com/device/K162273
Methodology: https://510kreport.com/methodology