# K230123: Apollo Knotless Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Maruho Medical
- Decided: May 3, 2023 after 106 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K911837 (1991). 100 ancestors in all.
No later device cites it as a predicate yet.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133036: Apollo Suture Anchor System and Titan Screws, Amendia, Inc. (2014) Summary page 4.
- K192810: Apollo Suture Anchor System, Valeris Medical (2020) Summary page 4.
- K220757: Argo Knotless SP Anchor, Conmed Corporation (2022) Summary page 4.

## Indications for use
The Apollo Knotless Suture Anchors are intended for use in soft tissue to bone fixation in areas such as the shoulder, elbow, knee, hip, wrist, hand, foot, and ankle.

Source page: https://510kreport.com/device/K230123
Methodology: https://510kreport.com/methodology