# K041288: Modification to Smartpin

- Pathway: 510(k) (Special)
- Applicant: Linvatec Biomaterials, Inc.
- Decided: Jun 10, 2004 after 28 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
Longest line of descent: 5 generations back to K864912 (1987). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010983: Plla Pin, Bionx Implants, Inc. (2001) Summary page 1.
- K003659: Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260, Bionx Implants, Inc. (2001) Summary page 1.
- K890902: Biofix* Biodegradable Fixation Rod, Davis & Geck, Inc. (1989) Summary page 1.
- K993074: Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525, Bionx Implants, Ltd. (1999) Summary page 1.
- K031981: 2.4 Smartnail, Models 532416, 532425, 532435, 532445, Linvatec Biomaterials, Ltd. (2003) Summary page 1.

## Most influential descendants
- 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
SmartPin® 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. SmartPin® is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of conical bone (except conical 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 SmartPin® upon the healing of growth plate has not been tested clinically.

Source page: https://510kreport.com/device/K041288
Methodology: https://510kreport.com/methodology