# K090953: Total Knee Surgetics Navigation System with Iblock

- Pathway: 510(k) (Special)
- Applicant: Praxim Medivision, SA
- Decided: Jan 21, 2010 after 293 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K002053 (2000). 25 ancestors in all.
17 later devices descend from it; 2 cite 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)
- K081232: Total Knee Surgetics Navigation System with Praxiteles, Praxim (2008) Summary page 2.

## Most influential descendants
- 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
- K240139: Real Intelligence™ CORI™ (2024), 3 descendants of its own

## Recalls of this device
- Apr 12, 2019 · Class II · Z-1717-2019: The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
- Oct 14, 2016 · Class III · Z-0610-2017: Incorrect lot number on outer kit

## Indications for use
The TOTAL KNEE SURGETICS Navigation System with iBlock 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/K090953
Methodology: https://510kreport.com/methodology