# K200642: OrthAlign Plus System

- Pathway: 510(k) (Special)
- Applicant: Orthalign, Inc.
- Decided: Apr 10, 2020 after 30 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: 14 generations back to K983831 (1999). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171780: OrthAlign Plus System, Orthalign, Inc. (2017) Summary page 4.

## 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 discrepancy 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/K200642
Methodology: https://510kreport.com/methodology