# K243742: Arthrex DynaNite Nitinol Staples

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jan 31, 2025 after 58 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: 11 generations back to K792022 (1979). 92 ancestors in all.
No later device cites it as a predicate yet.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203180: Arthrex DynaNite Nitinol Staples, Arthrex, Inc. (2020) Summary page 5.
- K172052: Arthrex DynaNite Nitinol Staple, Arthrex, Inc. (2017) Summary page 5.
- K232755: Arthrex FiberTape and TigerTape Cerclage Sutures, Arthrex, Inc. (2023) Summary page 5.
- K230976: Arthrex Radiopaque FiberTape Cerclage sutures, Arthrex, Inc. (2023) Summary page 5.

## Indications for use
The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus. The Arthrex DynaNite Nitinol Staples are indicated for: » Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. » Fixation of proximal tibial metaphysis osteotomy. » Hand and foot bone fragment and osteotomy fixation and joint arthrodesis. » Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum. » When used with Arthrex FiberTape Cerclage System, the Arthrex DynaNite Nitinol Staple (sizes 13x10 and 15x12 only) is intended for sternotomy indications including the “rewiring” of osteotomized sternums.

Source page: https://510kreport.com/device/K243742
Methodology: https://510kreport.com/methodology