# K241912: Biocharge

- Pathway: 510(k) (Special)
- Applicant: Nanofiber Solutions, LLC
- Decided: Jul 29, 2024 after 28 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K911837 (1991). 103 ancestors in all.
No later device cites it as a predicate yet.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231641: Rotium Bioresorbable Wick, Nanofiber Solutions, LLC (2023) Summary page 4.
- K201414: Rotium Bioresorbable Wick, Nanofiber Solutions, LLC (2020) Summary page 5.
- K183236: Rotium Bioresorbable Wick, Nanofiber Solutions, LLC (2019) Summary page 4.

## Indications for use
BIOCHARGE™ is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.

Source page: https://510kreport.com/device/K241912
Methodology: https://510kreport.com/methodology