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ApolloKnee

Corin U.S.A. Limited

Country / Region:United States (US)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K231172
Device name
ApolloKnee
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2023-04-25
Decision date
2023-07-26
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Knee SurgeryNavigation System
Primary application
Knee Surgery
Classification source
AI classified

Indications for Use

ApolloKnee is indicated to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee arthroplasty. Apollo Robot and BalanceBot are optional accessories and are specifically indicated for use in total knee arthroplasty with the ApolloKnee system. ApolloKnee is compatible with the following implant systems:
• Apex Knee™ System.
• Unity Knee™ System.
ApolloKnee is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate.

Intended Use

ApolloKnee is indicated to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee arthroplasty. Apollo Robot and BalanceBot are optional accessories and are specifically indicated for use in total knee arthroplasty with the ApolloKnee system. ApolloKnee is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate.

Device Description

ApolloKnee™ (formerly OMNIBotics) is a robotic-assisted stereotaxic surgery system that aids the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee replacement (TKR). ApolloKnee is composed of eight sub-systems that integrate to form the ApolloKnee system. Four of these sub-components (Station, Tracking System, Communication Module and Nonsurgical Application) form the main structure of Corin's core platform for robotic or computer assisted surgeries. This core platform is referred to as 'Apollo'. ApolloKnee includes four system specific sub-components (Apollo Robot, BalanceBot, TKR Instruments and ApolloKnee Software). ApolloKnee is an evolution of the former OMNIBotics Knee System. ApolloKnee differs from OMNIBotics Knee System in branding, as well as redesigns of the station and software, and introduction of additional surgical instrumentation, namely the BalanceBot Pre-Resection Paddles, Tibial Cutting Guide and V-Array.

Summary parsed at:2026-06-19 05:46:13 UTC

Predicate devices

1

K231172 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

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