# K992947: Cannulated Smartscrew Models 224540C, 224570C

- Pathway: 510(k) (Special)
- Applicant: Bionx Implants, Ltd.
- Decided: Sep 21, 1999 after 20 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: 2 generations back to K792022 (1979). 7 ancestors in all.
413 later devices descend from it; 5 cite it directly.
0 of 421 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 2.
- K974876: Bionx Distal Radius Screw, Bionx Implants, Inc. (1998) Summary page 2.

## Most influential descendants
- K012001: Smartscrew (2001), 337 descendants of its own
- 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

## Indications for use
Cannulated SmartScrew™ is intended for maintenance of alignment of cancellous fractures of the malleolus of the ankle in the presence of appropriate immobilization. In conjunction with adequate surgical technique and postoperative immobilization, the Cannulated SmartScrew™ provides secure fixation and will maintain sufficient physical integrity and mechanical holding properties within the bone, well beyond the five to eight weeks needed for complete biological healing and realignment of the fixation site. The Cannulated SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (diaphyseal area), 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/K992947
Methodology: https://510kreport.com/methodology