TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK— 510(k) K090953
Substantially EquivalentPraxim Medivision, SA
FDA 510(k) clearance K090953 for TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK, Substantially Equivalent on 2010-01-21. Applicant: Praxim Medivision, SA. Device class: 2.
Clearance details
- Applicant
- Praxim Medivision, SA
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- La Tronche, FR
Recent devices under product code OLO
view allMore clearances from Praxim Medivision, SA
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K090953
K-number listed on FDA's recall record- Z-1717-2019 — OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System.
- Z-0610-2017 — OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090953.
Data sourced from openFDA. This site is unofficial and independent of the FDA.