# K993074: Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525

- Pathway: 510(k) (Traditional)
- Applicant: Bionx Implants, Ltd.
- Decided: Dec 10, 1999 after 87 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: 1 generation back to K864912 (1987). 5 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890902: Biofix* Biodegradable Fixation Rod, Davis & Geck, Inc. (1989) Summary page 1.
- K925098: Biofix Absorbable Self-Reinforced Poly-L-Lactide, Bioscience, Inc. (1994) Summary page 1.
- K864912: PDS (Polydioxanon) Absorbable Pin, Johnson & Johnson Professionals, Inc. (1987) Summary page 1.
- K901456: Orthosorb (R) Absorbable Pin, Johnson & Johnson International (1990) Summary page 1.
- K961608: Synthes (U.S.a.) Polypin, Synthes (Usa) (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K882979: Orthosorb Absorbable Pin. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K012000: 1.5MM Bone Fixation Kit (2001), 5 descendants of its own
- K013546: Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214 (2001), 4 descendants of its own
- K031981: 2.4 Smartnail, Models 532416, 532425, 532435, 532445 (2003), 3 descendants of its own
- K041288: Modification to Smartpin (2004), 2 descendants of its own
- K073311: Osteotrans-OT Pin (2008), 0 descendants of its own

## Indications for use
The 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. The 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 and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of SmartNail™ upon the healing of growth plate has not been tested clinically.

Source page: https://510kreport.com/device/K993074
Methodology: https://510kreport.com/methodology