# K972517: Expert-XL Orthopedic Hip Acquisition and Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Lunar Corp.
- Decided: Nov 18, 1997 after 134 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- 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 K914404 (1992). 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)
- K914404: Ortho Software Used W/Lunar DPX/DPX-L/DPS-@ Desit, Lunar (1992) Summary page 1.

## Most influential descendants
- K133664: Encore Version 16 Software for GE Lunar Dxa Bone Densitometers (2014), 0 descendants of its own

## Indications for use
The EXPERT-XL Orthopedic Hip Acquisition and Analysis Software is used with the EXPERT-XL Bone Mineral Densitometry system. This new software feature allows for estimation of periprosthetic BMD of an orthopedic hip implant in sub-regions called Gruen zones. These zones are a typical radiographic labeling technique for orthopedic hip implants. The EXPERT-XL Orthopedic Hip Acquisition and Analysis Software requires a 12 seconds with an entrance radiation exposure to the skin of 53 mrem. This software posses no new safety or efficacy concerns. The use on the EXPERT-XL Orthopedic Hip Acquisition and Analysis Software is restricted to prescription only. The User’s Guide for the system contains the following statement: “United States Federal law restricts this device to the sale, distribution, and use by or on the order of a physician.”

Source page: https://510kreport.com/device/K972517
Methodology: https://510kreport.com/methodology