# K160284: JointPoint

- Pathway: 510(k) (Traditional)
- Applicant: Jointpoint, Inc.
- Decided: Aug 3, 2016 after 182 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 24 ancestors in all.
21 later devices descend from it; 7 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022364: Navitrack System Total Hip Replacement,Model 900.200, Orthosoft, Inc. (2003) Summary page 5.
- K142923: TraumaCad Mobile Release 1.0, Voyant Health, Ltd. (2015) Summary page 5.
- K073714: Traumacad Version 2.0, Orthocrat, Ltd. (2008) Summary page 5.
- K042816: Traumacad 1.2, Orthocrat, Ltd. (2004) Summary page 5.

## Most influential descendants
- K182332: PhantomMSK (2019), 5 descendants of its own
- K201928: e-Ortho Shoulder Software (2020), 4 descendants of its own
- K203651: Cuptimize (2021), 3 descendants of its own
- K210136: PhantomMSK Hip (2021), 3 descendants of its own
- K213922: FX SPS (2022), 2 descendants of its own

## Indications for use
JointPoint is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images. JointPoint is also indicated for assisting healthcare professionals in preoperative planning and postoperative analysis of orthopedic surgery in Total Hip Replacement, Total Knee Replacement, and Intertrochanteric Fracture Reduction. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

Source page: https://510kreport.com/device/K160284
Methodology: https://510kreport.com/methodology