# K111492: Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Oct 13, 2011 after 135 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K082358 (2008). 2 ancestors in all.
314 later devices descend from it; 7 cite it directly.
1 of 317 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093533: Zimmer Patient Specific Instruments System, Version 2.0, Materialise NV (2010) Summary page 1.

## Most influential descendants
- K113666: Xia 3 Spinal System (2012), 251 descendants of its own
- K133350: Revere Stabilization System (2014), 93 descendants of its own
- K133188: Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal (2013), 84 descendants of its own
- K142381: Xia 3 Spinal System (2014), 83 descendants of its own
- K130932: Firebird Spinal Fixation System (2013), 81 descendants of its own

## Recalls of this device
- Mar 23, 2012 · Not classified · Z-1543-2012: March 23, 2012 a field representative reported patient specific -0242-L tibia guide case packaging contained a different patient specific -0864-R tibia guide. The two patient specific products had bee
- Mar 23, 2012 · Not classified · Z-1544-2012: March 23, 2012 a field representative reported patient specific --0242 L tibia guide case packaging contained a different patient specific ..-0864-R tibia guide. The two patient specific products had 

## 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 piatient 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 NEXCEN IPS-FLEX fixed bearing, Zimmer NEXGEN IPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses families only. The Zimmer Patient Specific Instruments are intended for single use only.

Source page: https://510kreport.com/device/K111492
Methodology: https://510kreport.com/methodology