# K050259: Arthrex Bio-Pin

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: May 27, 2005 after 113 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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
No predicates in its family tree.
31 later devices descend from it; 16 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K110445: Flexfusion (TM) Fixation Implant (2011), 16 descendants of its own
- K122031: Nextra TI Hammertoe Correction System (2012), 9 descendants of its own
- K160264: Additive Orthopaedics Hammertoe Correction System (2016), 4 descendants of its own
- K130859: Hammertoe Correction System (2013), 4 descendants of its own
- K200840: DuoHex CH Cannulated Hammertoe System (2020), 3 descendants of its own

## Indications for use
The Arthrex Bio-Pins are poly-L-Lactide based implants used to fix small bony or apical chondral fragments in the Foot, Ankle, Upper Extremities, Hand, and Wrist, where such fragments are not under tension or load-bearing. These pins are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), upper extremity fractures, cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The Bio-Pins can be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of digital deformities of the foot or hand. The Bio-Pin is also used in inherently stable long bone fractures such as the femur, fibula, tibia, humerus, radius and ulna including the diaphyseal, epiphyseal, and metaphyseal areas.

Source page: https://510kreport.com/device/K050259
Methodology: https://510kreport.com/methodology