# K081232: Total Knee Surgetics Navigation System with Praxiteles

- Pathway: 510(k) (Traditional)
- Applicant: Praxim
- Decided: Aug 6, 2008 after 97 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: 6 generations back to K002053 (2000). 24 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060282: Total Knee Surgetics Navigation System, Praxim S.A (2006) Summary page 1.
- K061362: Pigalileo Total Knee Replacement (TKR) System, Plus Orthopedics AG (2006) Summary page 1.
- K063408: Ctlogics Navigations Systems, Praxim Medivision, SA (2007) Summary page 1.

## Most influential descendants
- K090953: Total Knee Surgetics Navigation System with Iblock (2010), 17 descendants of its own
- K163338: OMNIBotics Knee System (2017), 12 descendants of its own
- K200888: OMNIBotics Knee System (2020), 11 descendants of its own
- K221224: Real Intelligence Cori (2022), 9 descendants of its own
- K231963: Real Intelligence™ Cori™ (2023), 4 descendants of its own

## Indications for use
The TOTAL KNEE SURGETICS Navigation System with Praxiteles is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: *Total Knee Arthroplasty

Source page: https://510kreport.com/device/K081232
Methodology: https://510kreport.com/methodology