# K091411: Kneealign System

- Pathway: 510(k) (Traditional)
- Applicant: Orthalign, Inc.
- Decided: Sep 25, 2009 after 135 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: 6 generations back to K983831 (1999). 15 ancestors in all.
41 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073615: Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited, Brainlab AG (2008) Summary page 1.
- K060282: Total Knee Surgetics Navigation System, Praxim S.A (2006) Summary page 1.

## Most influential descendants
- K093998: Kneealign System with Reference Sensor (2010), 40 descendants of its own
- K103829: Kneealign System (2011), 39 descendants of its own
- 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

## Indications for use
The KneeAlign TM 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 TM 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/tibial resection

Source page: https://510kreport.com/device/K091411
Methodology: https://510kreport.com/methodology