# K012001: Smartscrew

- Pathway: 510(k) (Special)
- Applicant: Bionx Implants, Ltd.
- Decided: Jul 18, 2001 after 21 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: 3 generations back to K792022 (1979). 9 ancestors in all.
337 later devices descend from it; 6 cite it directly.
0 of 347 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952471: Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation Rod, Bioscience, Inc. (1995) Summary page 1.
- K974876: Bionx Distal Radius Screw, Bionx Implants, Inc. (1998) Summary page 1.
- K992947: Cannulated Smartscrew Models 224540C, 224570C, Bionx Implants, Ltd. (1999) Summary page 1.
- K003077: Smartscrew Model 222006...227510, Bionx Implants, Ltd. (2001) Summary page 1.

## Most influential descendants
- K030900: Inion Otps Biodegradable Fixaton System (2003), 333 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K083070: Toggleloc System (2008), 94 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own

## Indications for use
The SmartScrew™ 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 of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus. The SmartScrew™ 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).

Source page: https://510kreport.com/device/K012001
Methodology: https://510kreport.com/methodology