# K153237: OrthAlign Plus System

- Pathway: 510(k) (Traditional)
- Applicant: Orthalign, Inc.
- Decided: Mar 1, 2016 after 113 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: 11 generations back to K983831 (1999). 39 ancestors in all.
18 later devices descend from it; 2 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)
- K140331: Orthalign Plus System, Orthalign, Inc. (2014) Summary page 4.
- K141694: Aesculap Orthopilot Next Generation, Aesculap Implant Systems, LLC (2015) Summary page 4.

## Most influential descendants
- K162962: OrthAlign Plus System (2017), 15 descendants of its own
- 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

## 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 * Unicompartmental Knee Arthroplasty: Tibial transverse resection

Source page: https://510kreport.com/device/K153237
Methodology: https://510kreport.com/methodology