# K183544: Efficient Care 3D Planning

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft Inc (D/B/A Zimmer Cas)
- Decided: Aug 23, 2019 after 246 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). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161828: kneeEOS, Onefit Medical (2016) Summary page 4.

## Most influential descendants
- K202487: HealthJOINT (2020), 0 descendants of its own

## Indications for use
Efficient Care 3D Planning is software indicated for assisting orthopedic surgeons in preoperative planning of knee orthopedic surgeries. The software allows for the overlaying of 3D/2D implant models and for the visualization of the radiological images and 3D reconstruction of bones, and includes tools for performing measurements on the images or 3D model of bones, and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software. Efficient Care 3D Planning is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Vanguard® CR, and Vanguard PS.

Source page: https://510kreport.com/device/K183544
Methodology: https://510kreport.com/methodology