# K093533: Zimmer Patient Specific Instruments System, Version 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Feb 17, 2010 after 93 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K082358 (2008). 1 ancestor in all.
404 later devices descend from it; 4 cite it directly.
1 of 406 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082358: Smith & Nephew, Inc. Patient Matched Technology, Smith & Nephew, Inc. (2008) Summary page 1.

## Most influential descendants
- K111492: Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments (2011), 314 descendants of its own
- K113666: Xia 3 Spinal System (2012), 251 descendants of its own
- K102795: Signature Planner; Signature Guides (2011), 99 descendants of its own
- K133350: Revere Stabilization System (2014), 93 descendants of its own
- K103136: Surgicase CMF, Surgicase Connect, Surgicase Guide (2011), 90 descendants of its own

## 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. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN LPS-FLEX 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/K093533
Methodology: https://510kreport.com/methodology