# K200384: HipXpert 3D Display and Anchoring Application

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Planning Associates, Inc.
- Decided: Jan 28, 2021 after 345 days
- Product code: OSF (Patient Specific Manual Orthopedic Stereotaxic System)
- 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: 1 generation back to K093491 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093491: Hip Sextant Instrument System, Surgical Planning Associates (2010) Summary page 4.

## Most influential descendants
- K233315: HipXpert and HipInsight System (2024), 0 descendants of its own

## Indications for use
The HipXpert system is a manual surgical instrument and associated software application designed for use in planning surgery and aligning the acetabular components during hip arthroplasty procedures. The HipXpert 3D Display and Anchoring application with the HoloLens2 is indicated for visual alignment of an acetabular cup impactor during hip arthroplasty when pin-based fixation of the HipXpert tool is utilized.

Source page: https://510kreport.com/device/K200384
Methodology: https://510kreport.com/methodology