# K191507: Intellijoint® Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Intellijoint Surgical, Inc.
- Decided: Oct 1, 2019 after 117 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: 11 generations back to K010612 (2001). 39 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103829: Kneealign System, Orthalign, Inc. (2011) Summary page 4.
- K171525: Intellijoint HIP Generation 2B System, Intellijoint Surgical, Inc. (2017) Summary page 4.

## Most influential descendants
- K252847: NextAR Hip Platform (2026), 0 descendants of its own
- K223351: Naviswiss Knee (2023), 0 descendants of its own

## Recalls of this device
- Aug 28, 2026 · Class II · Z-0119-2027: A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recal
- Feb 11, 2020 · Class II · Z-1559-2020: During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.

## Indications for use
The Intellijoint® Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. The Intellijoint Navigation System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective. Intellijoint HIP aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning. Intellijoint KNEE aids the surgeon in performing intra-operative measurements including alignment of instrumentation and bony cuts for implant component positioning. Example orthopedic surgical procedures include, but are not limited to: - Total Hip Arthroplasty - Minimally Invasive Hip Arthroplasty - Revision Hip Arthroplasty - Total Knee Arthroplasty

Source page: https://510kreport.com/device/K191507
Methodology: https://510kreport.com/methodology