# K131637: Rotation Medical Soft Tissue Staple (RMST Staple)

- Pathway: 510(k) (Traditional)
- Applicant: Rotation Medical, Inc.
- Decided: Jul 12, 2013 after 38 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K951658 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093845: Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25, ETHICON, Inc. (2010) Summary page 1.

## Most influential descendants
- K222487: Anika Tissue Tack Fixation System (2023), 0 descendants of its own

## Recalls of this device
- Aug 12, 2024 · Class II · Z-3097-2024: Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
- Aug 12, 2024 · Class II · Z-3096-2024: Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility

## Indications for use
The RMST Staple is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Source page: https://510kreport.com/device/K131637
Methodology: https://510kreport.com/methodology