# K100314: Imns Medacta Navigation System,33.221000US

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Mar 31, 2010 after 55 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- 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: 5 generations back to K002053 (2000). 11 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083872: Imns Medacta Navigation System, Medacta International S.A. (2009) Summary page 1.

## Most influential descendants
- K193559: NextAR TKA Platform (2020), 12 descendants of its own
- K202152: NextAR TKA Platform (2020), 11 descendants of its own
- K210153: NextAR RSA Platform (2021), 5 descendants of its own
- K210859: NextAR™ Spine Platform (2021), 4 descendants of its own
- K223769: NextAR™ Spine Platform (2023), 2 descendants of its own

## Indications for use
The iMNS Medacta Navigation System is intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, instrument and implant positioning during joint replacement. The iMNS Medlacta Navigation System provides computer assistance to the surgeon based on anatomical landmarks and other specific data obtained intra-operatively that are used to place surgical instruments. Examples of some surgical procedures include but are not limited to: Total Knee Replacement Minimally Invasive Total Knee Replacement

Source page: https://510kreport.com/device/K100314
Methodology: https://510kreport.com/methodology