# K171525: Intellijoint HIP Generation 2B System

- Pathway: 510(k) (Traditional)
- Applicant: Intellijoint Surgical, Inc.
- Decided: Oct 30, 2017 after 158 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: 10 generations back to K010612 (2001). 26 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162364: Intellijoint HIP Generation 2A System, Intellijoint Surgical, Inc. (2017) Summary page 4.
- K162937: Stryker OrthoMap Versatile Hip System, Stryker Corporation (2017) Summary page 4.

## Most influential descendants
- K191507: Intellijoint® Navigation System (2019), 2 descendants of its own
- K252847: NextAR Hip Platform (2026), 0 descendants of its own
- K223351: Naviswiss Knee (2023), 0 descendants of its own

## Indications for use
The Intellijoint HIP Generation 2B 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 HIP Generation 2B System is indicated for patients undergoing orthopedic 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 orthopedic surgical procedures include, but are not limited to: - Total Hip Arthroplasty - Minimally Invasive Hip Arthroplasty - Revision Hip Arthroplasty

Source page: https://510kreport.com/device/K171525
Methodology: https://510kreport.com/methodology