# K153129: dynaMX Tabbed Staple

- Pathway: 510(k) (Traditional)
- Applicant: Mx Orthopedics, Corp.
- Decided: Jan 28, 2016 after 90 days
- Product code: JDR (Staple, Fixation, Bone)
- 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: 3 generations back to K902307 (1990). 5 ancestors in all.
2 later devices descend 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)
- K102107: Osstaple Chill, Biomedical Ent., Inc. (2010) Summary page 4.
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 4.
- K143622: dynaMX Compression Staple, Mx Orthopedics, Corp. (2015) Summary page 4.

## Most influential descendants
- K172052: Arthrex DynaNite Nitinol Staple (2017), 1 descendant of its own
- K243742: Arthrex DynaNite Nitinol Staples (2025), 0 descendants of its own

## Indications for use
The dynaMX™ Tabbed Staple is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and, Fixation of proximal tibial metaphysis osteotomy.

Source page: https://510kreport.com/device/K153129
Methodology: https://510kreport.com/methodology