# K172462: OrthAlign Plus System

- Pathway: 510(k) (Traditional)
- Applicant: Orthalign, Inc.
- Decided: Nov 22, 2017 after 100 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). 51 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 60 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.
- K102251: Dash Knee, Brainlab AG (2011) Summary page 4.
- K150372: VERASENSE Knee System, Orthosensor, Inc. (2016) Summary page 4.

## Most influential descendants
- K203115: ARVIS Surgical Navigation System (2021), 3 descendants of its own
- K240062: ARVIS® Shoulder (2024), 1 descendant of its own
- K200376: Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration (2020), 1 descendant of its own
- K193580: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left (2020), 1 descendant of its own
- K261410: Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) (2026), 0 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. Ligament balancing is provided by the OrthAlign Plus® System in primary or revision Total Knee 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 * Ligament Balancing

Source page: https://510kreport.com/device/K172462
Methodology: https://510kreport.com/methodology