# K090375: Orthopilot Next Generation-Uka Software, Model FS210

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant System, Inc.
- Decided: Jun 23, 2009 after 126 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: 3 generations back to K003347 (2001). 6 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080547: Orthopilot Next Generation, Model FS101-FS106, Aesculap Implant System, Inc. (2008) Summary page 2.

## Most influential descendants
- K141694: Aesculap Orthopilot Next Generation (2015), 19 descendants of its own
- K153237: OrthAlign Plus System (2016), 18 descendants of its own
- 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

## Indications for use
The OrthoPilot® Next Generation Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endoprosthesis replacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurements of bone alignment. It indicates angles and positions for implant placement.

Source page: https://510kreport.com/device/K090375
Methodology: https://510kreport.com/methodology