# K231172: ApolloKnee

- Pathway: 510(k) (Traditional)
- Applicant: Corin U.S.A. Limited
- Decided: Jul 26, 2023 after 92 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K002053 (2000). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200888: OMNIBotics Knee System, Corin, Ltd. (2020) Summary page 4.

## 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.

Source page: https://510kreport.com/device/K231172
Methodology: https://510kreport.com/methodology