# K200892: Harvey (R) Surgical Assistant

- Pathway: 510(k) (Special)
- Applicant: Orthalign, Inc.
- Decided: Jun 18, 2020 after 76 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K983831 (1999). 44 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162962: OrthAlign Plus System, Orthalign, Inc. (2017) Summary page 4.

## Most influential descendants
- K262253: Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) (2026), 0 descendants of its own
- K253507: Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee (2026), 0 descendants of its own

## Recalls of this device
- Feb 10, 2026 · Class II · Z-1630-2026: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
- Feb 10, 2026 · Class II · Z-1629-2026: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

## Indications for use
The HSA 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 HSA 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 • Unicompartmental Knee Arthroplasty: Tibial transverse resection.

Source page: https://510kreport.com/device/K200892
Methodology: https://510kreport.com/methodology