# K130387: Orthoalign Plus System

- Pathway: 510(k) (Traditional)
- Applicant: Orthalign, Inc.
- Decided: Nov 8, 2013 after 266 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: 9 generations back to K983831 (1999). 23 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 55 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.
- K043536: Navitrack System - S&N Image Free Knee, Orthosoft, Inc. (2005) Summary page 1.
- K041369: Navitrack System - S&N Image Free Hip, Model Pro-03017, Orthosoft, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K150741: TSolution One w/ACG surgical System (2015), 9 descendants of its own

## Indications for use
The OrthAlign Plus m System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus m System facilitates the accurate positioning of implants, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: * Total Knee Arthroplasty * Total Hip Arthroplasty: Anterior / Posterior The KneeAlign® 3 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The KneeAlign® 3 System facilitates the accurate positioning of implants, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: * Total Knee Arthroplasty The HipAlign System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The HipAlign System facilitates the accurate positioning of implants, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: * Total Hip Arthroplasty: Anterior / Posterior

Source page: https://510kreport.com/device/K130387
Methodology: https://510kreport.com/methodology