# K133162: Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Pla

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Feb 25, 2014 after 131 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: 6 generations back to K924630 (1993). 10 ancestors in all.
13 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)
- K121640: Zimmer Patient Specific Instruments System, Materialise NV (2012) Summary page 1.

## Most influential descendants
- K150928: Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides (2015), 12 descendants of its own
- 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

## Indications for use
Total Knee Replacement The ZimmerO Patient Specific Instruments 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 Zimmer* Patient Specific Instruments 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 TMCR fixed bearing, Zimmer PersonaT PS fixed bearing and Zimmer Persona T Trabecular Metal TM prostheses families only. Unicompartmental Knee Replacement The ZimmerO Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental 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 ZimmerO Patient Specific Instruments System isto be used with Zimmer Unicampartmental High Flex Knee System prostheses families only. The Zimmer' Patient Specific Instruments are intended for single use only.

Source page: https://510kreport.com/device/K133162
Methodology: https://510kreport.com/methodology