# K020222: Wisorb Malleolar Screw

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Scientific, Inc.
- Decided: Jul 29, 2002 after 188 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). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 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.
- K920188: Threaded Pins, Kirschner Medical Corp. (1993) Summary page 1.
- K974876: Bionx Distal Radius Screw, Bionx Implants, Inc. (1998) Summary page 1.

## Most influential descendants
- K040265: Little Grafter Screw (2004), 1 descendant of its own
- K073312: Osteotrans-OT Screw (2008), 0 descendants of its own

## Indications for use
The WISORBm malleolar screw is intended for use in bone-to-bone fixation in the metaphyseal area, distal humerous, trochanteric area and in the ankle where the bone is dense. The WISORBm malleolar screw is intended primarily for internal fixation of fractures with minimal displacement commonly seen in fractures of the ankle and foot, such as, transverse fibular fractures at or distal to the ankle joint (Danis-Weber Type A); low spiral fractures of the lateral malleolus, avulsion fractures of the medial malleolus (Dyputren; Dank-Weber Type-B), avulsion fractures of the posterior malleolus (Volkmann’s Triangle). Other fractures that maybe suitable for treatment with the WISORBTMmalleolar screw include distal radial fractures (Type Colles), which typically occur at the metaphyseal portion of the bone proximal to the extensor tendon sheaths. The WISORBm malleolar screw is not intended for use in and is contraindicated for: Fractures of cortical bone (diaphyseal area) Situations of active or potential infection or where patient cooperation cannot be guaranteed.

Source page: https://510kreport.com/device/K020222
Methodology: https://510kreport.com/methodology