Manufacturer
Corin U.S.A. LimitedApolloKnee
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K231172
- Device name
- ApolloKnee
- Company
- Corin U.S.A. Limited
- 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
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Cited as predicate
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