# K142944: ArthroPlan Digital Templating Software

- Pathway: 510(k) (Traditional)
- Applicant: Arthromeda, Inc.
- Decided: Dec 16, 2014 after 67 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: 8 generations back to K896095 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063327: Orthoview, Merdian Technique, Ltd. (2006) Summary page 4.
- K071972: Orthopedic Software for Impax Workstations, Agfa Healthcare Corp. (2007) Summary page 4.

## Indications for use
ArthroPlan™ is indicated for use by suitably licensed and qualified healthcare professionals requiring access to medical images to be used in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the size and geometry of the prosthetic/fixation device when planning a potential hip arthroplasty surgical procedure. Templating is done without alteration of the original image, using scaling and measurement tools in a digital environment, in conjunction with manufacturers’ templates available via the ArthroPlan library of digital templates for prosthetic and fixation devices.

Source page: https://510kreport.com/device/K142944
Methodology: https://510kreport.com/methodology