# K202207: Materialise PKA Guide System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Oct 2, 2020 after 57 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: 11 generations back to K924630 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173970: Materialise PKA Guide System, Materialise NV (2018) Summary page 6.

## Indications for use
Hardware • Guides The Materialise PKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Partial Knee Replacement components and in guiding the marking of bone before cutting and to guide cutting of the bone. The Materialise PKA Guides must be used in conjunction with the compatible prostheses families only: ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems, Vanguard™ M Unicompartmental Knee System, Oxford® Partial Knee System and Persona® Partial Knee System. The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014. The Materialise PKA Guides are intended for single use only. • Models The Materialise PKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Partial Knee Replacement components. The Materialise PKA Models must be used in conjunction with the compatible prostheses families only: ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems, Vanguard™ M Unicompartmental Knee System, Oxford® Partial Knee System and Persona® Partial Knee System. The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014. The Materialise PKA Models are intended for single use only. Software The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.

Source page: https://510kreport.com/device/K202207
Methodology: https://510kreport.com/methodology