# K131635: Rotation Medical Bone Staple (RMB Staple)

- Pathway: 510(k) (Traditional)
- Applicant: Rotation Medical, Inc.
- Decided: Aug 29, 2013 after 86 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: 7 generations back to K961555 (1996). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 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.
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 1.

## Most influential descendants
- K223860: Integrity™ Bone Staple Fixation System (2023), 1 descendant of its own
- K261869: Integrity Retractable Implant Inserter (6000127) (2026), 0 descendants of its own
- K213958: Bioabsorbable Anchor (2022), 0 descendants of its own

## Indications for use
The RMB Staple is indicated for fixation of soft tissue grafts during rotator cuff repair.

Source page: https://510kreport.com/device/K131635
Methodology: https://510kreport.com/methodology