# K150928: Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Aug 10, 2015 after 126 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: 7 generations back to K924630 (1993). 11 ancestors in all.
12 later devices descend from it; 1 cites 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)
- K133162: Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Pla, Materialise NV (2014) Summary page 4.
- K102795: Signature Planner; Signature Guides, Materialise NV (2011) Summary page 5.

## Most influential descendants
- K162273: Materialise TKA Guide System (2016), 11 descendants of its own
- 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

## 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 PersonaTM CR fixed bearing, Zimmer PersonaTM PS fixed bearing, Zimmer PersonaTM Trabecular MetalTM, 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 TM Total Knee System, and AGC® Complete Knee system, and Consensus Knee System prostheses families only. The Materialise TKA Guides are intended for single use only.

Source page: https://510kreport.com/device/K150928
Methodology: https://510kreport.com/methodology