# K162962: OrthAlign Plus System

- Pathway: 510(k) (Traditional)
- Applicant: Orthalign, Inc.
- Decided: Jan 23, 2017 after 91 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: 12 generations back to K983831 (1999). 43 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153237: OrthAlign Plus System, Orthalign, Inc. (2016) Summary page 4.
- K050615: Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000, Stryker Instruments (2005) Summary page 4.

## Most influential descendants
- K171780: OrthAlign Plus System (2017), 12 descendants of its own
- K172462: OrthAlign Plus System (2017), 8 descendants of its own
- K203115: ARVIS Surgical Navigation System (2021), 3 descendants of its own
- K200892: Harvey (R) Surgical Assistant (2020), 2 descendants of its own
- K242616: Lantern® Hip (2024), 1 descendant 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. Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty Total Hip Arthroplasty: Anterior/Posterior Unicompartmental Knee Arthroplasty: Tibial transverse resection

Source page: https://510kreport.com/device/K162962
Methodology: https://510kreport.com/methodology