# K172650: Materialise PKA Guide System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Nov 20, 2017 after 76 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K924630 (1993). 18 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112301: Zimmer Patient Specific Instruments Planner, Materialise NV (2012) Summary page 5.
- K162273: Materialise TKA Guide System, Materialise NV (2016) Summary page 5.

## 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
- 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
The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems prostheses families only. The Materialise PKA Guides are intended for single use only.

Source page: https://510kreport.com/device/K172650
Methodology: https://510kreport.com/methodology