# K233315: HipXpert and HipInsight System

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Planning Associates, Inc.
- Decided: Aug 8, 2024 after 314 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: 2 generations back to K093491 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200384: HipXpert 3D Display and Anchoring Application, Surgical Planning Associates, Inc. (2021) Summary page 4.

## 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 Hiplnsight system with the HoloLens2 is indicated for visualization of the HipXpert surgical plan and alignment of acetabular implants and instrumentation during hip arthroplasty when pin-based fixation of the HipXpert tools is utilized.

Source page: https://510kreport.com/device/K233315
Methodology: https://510kreport.com/methodology