# K242494: OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct

- Pathway: 510(k) (Traditional)
- Applicant: Riverpoint Medical, LLC
- Decided: Nov 26, 2024 after 96 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: 10 generations back to K792022 (1979). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203740: JuggerKnot Soft Anchor, Riverpoint Medical (2021) Summary page 5.

## Indications for use
The OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct are intended for use in soft tissue to bone fixation for the following indications: Shoulder Rotator Cuff Repair

Source page: https://510kreport.com/device/K242494
Methodology: https://510kreport.com/methodology