# K122326: Smarttools Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer
- Decided: Nov 30, 2012 after 121 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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: 9 generations back to K983831 (1999). 19 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103829: Kneealign System, Orthalign, Inc. (2011) Summary page 1.

## Most influential descendants
- K141601: Iassist Knee System (2014), 2 descendants of its own
- K192080: iASSIST Knee System (2019), 1 descendant of its own
- K213033: iASSIST Knee System (2022), 0 descendants of its own

## Recalls of this device
- Feb 20, 2017 · Class II · Z-1868-2017: There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P
- Apr 19, 2015 · Class II · Z-1701-2015: Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.

## Indications for use
The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and implant components relative to these axes. Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.

Source page: https://510kreport.com/device/K122326
Methodology: https://510kreport.com/methodology