# K103829: Kneealign System

- Pathway: 510(k) (Traditional)
- Applicant: Orthalign, Inc.
- Decided: Apr 4, 2011 after 95 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K983831 (1999). 18 ancestors in all.
39 later devices descend from it; 4 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093998: Kneealign System with Reference Sensor, Orthalign, Inc. (2010) Summary page 1.
- K043536: Navitrack System - S&N Image Free Knee, Orthosoft, Inc. (2005) Summary page 1.

## Most influential descendants
- K130387: Orthoalign Plus System (2013), 31 descendants of its own
- K140331: Orthalign Plus System (2014), 29 descendants of its own
- K153237: OrthAlign Plus System (2016), 18 descendants of its own
- K162962: OrthAlign Plus System (2017), 15 descendants of its own
- K171780: OrthAlign Plus System (2017), 12 descendants of its own

## Indications for use
The KneeAlign® 2 System is a computer controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign® 2 System facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: *Total Knee Arthroplasty

Source page: https://510kreport.com/device/K103829
Methodology: https://510kreport.com/methodology