# K042295: Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020

- Pathway: 510(k) (Special)
- Applicant: Linvatec Biomaterials, Ltd.
- Decided: Sep 16, 2004 after 23 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 4 generations back to K792022 (1979). 10 ancestors in all.
1 later device descends 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)
- K012001: Smartscrew, Bionx Implants, Ltd. (2001) Summary page 1.

## Most influential descendants
- K050388: Refix Internal Fracture Fixation Screws (2005), 0 descendants of its own

## Indications for use
SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies, malleolar fractures, ankle fractures, metatarsal osteotomies and correction of hallux valgus. SmartScrew® II is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures. 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism). 3) Highly comminuted fractures, which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.

Source page: https://510kreport.com/device/K042295
Methodology: https://510kreport.com/methodology