# K031981: 2.4 Smartnail, Models 532416, 532425, 532435, 532445

- Pathway: 510(k) (Special)
- Applicant: Linvatec Biomaterials, Ltd.
- Decided: Jul 25, 2003 after 29 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- 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: 4 generations back to K864912 (1987). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993074: Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525, Bionx Implants, Ltd. (1999) Summary page 1.
- K012000: 1.5MM Bone Fixation Kit, Bionx Implants, Ltd. (2001)
- K013546: Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214, Bionx Implants, Inc. (2001) Summary page 1.

## Most influential descendants
- K041288: Modification to Smartpin (2004), 2 descendants of its own
- K073311: Osteotrans-OT Pin (2008), 0 descendants of its own
- K071616: Arc Surgical Biotrak Pin System (2007), 0 descendants of its own

## Indications for use
2.4 SmartNail is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments. 2.4 SmartNail is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed, (e.g., alcoholism) 4) Treatment of physeal fractures in children, because the effect of 2.4 SmartNail upon the healing of growth plate has not been tested clinically.

Source page: https://510kreport.com/device/K031981
Methodology: https://510kreport.com/methodology