# K231641: Rotium Bioresorbable Wick

- Pathway: 510(k) (Special)
- Applicant: Nanofiber Solutions, LLC
- Decided: Jul 5, 2023 after 30 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: 15 generations back to K911837 (1991). 102 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K241912: Biocharge (2024), 0 descendants of its own

## Indications for use
The Rotium™ Bioresorbable Wick 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/K231641
Methodology: https://510kreport.com/methodology