# K121640: Zimmer Patient Specific Instruments System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Dec 5, 2012 after 184 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: 5 generations back to K924630 (1993). 9 ancestors in all.
60 later devices descend from it; 4 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111492: Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments, Materialise NV (2011) Summary page 2.
- K102795: Signature Planner; Signature Guides, Materialise NV (2011) Summary page 2.

## Most influential descendants
- K131129: Cas Psi Shoulder (2013), 39 descendants of its own
- K143374: BLUEPRINT Patient Specific Instrumentation (2015), 31 descendants of its own
- K160555: BLUEPRINT Patient Specific Instrumentation (2016), 25 descendants of its own
- K162800: BLUEPRINT Patient Specific Instrumentation (2017), 23 descendants of its own
- K203315: BLUEPRINT™ Patient Specific Instrumentation (2021), 18 descendants of its own

## Recalls of this device
- Oct 16, 2014 · Class II · Z-0418-2015: The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia gu

## Indications for use
The Zimmer 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 Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses families only. The Zimmer Patient Specific Instruments are intended for single use only.

Source page: https://510kreport.com/device/K121640
Methodology: https://510kreport.com/methodology