# K140331: Orthalign Plus System

- Pathway: 510(k) (Traditional)
- Applicant: Orthalign, Inc.
- Decided: Jun 10, 2014 after 120 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: 10 generations back to K983831 (1999). 33 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130387: Orthoalign Plus System, Orthalign, Inc. (2013) Summary page 1.
- K041369: Navitrack System - S&N Image Free Hip, Model Pro-03017, Orthosoft, Inc. (2004) Summary page 1.
- K110021: Dash Hip, Brainlab AG (2011) Summary page 1.

## Most influential descendants
- 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
- K172462: OrthAlign Plus System (2017), 8 descendants of its own

## Indications for use
The OrthAlign Plus® 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® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior. 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. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior. Example orthopedic surgical procedures include but are not limited to: Total Hip Arthroplasty: Anterior / Posterior

Source page: https://510kreport.com/device/K140331
Methodology: https://510kreport.com/methodology