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iASSIST Knee System

Orthosoft Inc. (d/b/a) Zimmer CAS

Country / Region:Canada (CA)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Product code

OLO
21 CFR 882.4560

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K213033
Device name
iASSIST Knee System
Country / Region
Canada(CA)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2021-09-21
Decision date
2022-01-14
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Knee Surgery
Primary application
Knee Surgery
Classification source
AI classified

Indications for Use

The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system intended to assist the surgeon in preparing the bone surfaces for the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and inertial sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and cut guides relative to these axes. The present iASSIST Knee System is designed for Total Knee Arthroplasty.

Intended Use

The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system intended to assist the surgeon in preparing the bone surfaces for the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and inertial sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and cut guides relative to these axes. The present iASSIST Knee System is designed for Total Knee Arthroplasty.

Device Description

The iASSIST Knee System consists of Pods (tracking sensors), a computer system, software, and surgical instruments designed to assist the surgeon in the placement of Total Knee Replacement components. The Pods combined with the surgical instruments provide positional information to help orient and locate the main femoral and tibial cutting planes as required in knee replacement surgery. This includes means for the surgeon to determine and thereafter track each of the bones' alignment axes relative to which the cutting planes are set. The computer system and software components control and sequence the functions of the Pods per the applicable knee surgery steps via wireless communication.

Summary parsed at:2026-06-24 04:14:21 UTC

Predicate devices

3

K213033 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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