# K151364: Intellijoint HIP (tm) System

- Pathway: 510(k) (Traditional)
- Applicant: Intellijoint Surgical, Inc.
- Decided: Dec 28, 2015 after 221 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: 8 generations back to K010612 (2001). 22 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133759: Intellijoint Hip, Intellijoint Surgical, Inc. (2014) Summary page 4.
- K041369: Navitrack System - S&N Image Free Hip, Model Pro-03017, Orthosoft, Inc. (2004) Summary page 4.

## Most influential descendants
- K162364: Intellijoint HIP Generation 2A System (2017), 7 descendants of its own
- K171525: Intellijoint HIP Generation 2B System (2017), 3 descendants of its own
- K191507: Intellijoint® Navigation System (2019), 2 descendants of its own
- K193094: Naviswiss Hip Navigation System (2020), 1 descendant of its own
- K172849: Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray (2017), 1 descendant of its own

## Indications for use
Intellijoint HIP is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors. Intellijoint HIP is indicated for patients undergoing orthopaedic surgery, and where the use of stereotactic surgery is considered safe and effective. The system aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning. Example orthopaedic surgical procedures include, but are not limited to: - Total Hip Arthroplasty - Minimally Invasive Hip Arthroplasty

Source page: https://510kreport.com/device/K151364
Methodology: https://510kreport.com/methodology