# K173445: Materialise TKA Guide System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Feb 2, 2018 after 88 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K924630 (1993). 16 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162273: Materialise TKA Guide System, Materialise NV (2016) Summary page 6.
- K110415: Signature Planner / Signature Guides, Materialise NV (2011) Summary page 6.
- K140027: Zimmer Patient Specific Instruments/ System/Planner, Materialise NV (2014) Summary page 6.

## Most influential descendants
- 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
- K221337: Materialise TKA Guide System (2022), 2 descendants of its own
- K251554: Materialise TKA Guide System (2025), 1 descendant of its own

## Recalls of this device
- Apr 26, 2023 · Class II · Z-2213-2023: The wrong tibia guide was included intended for a different patient case.

## Indications for use
Pin Placement Guides The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the intra-operative positioning of total knee replacement components and in guiding the marking of bone before cutting. The Materialise TKA Guide System must be used in conjunction with the 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 prostheses families only. The Materialise TKA Guides are intended for single use only. Cut-Through Guides The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the intra-operative positioning of total knee replacement components and in guiding the marking of bone before cutting and cutting of the bone. The Materialise TKA Guide System must be used in conjunction with 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 and AGC™ Complete Knee system prostheses families only The Materialise TKA Guides are intended for single use only.

Source page: https://510kreport.com/device/K173445
Methodology: https://510kreport.com/methodology