# K082574: Maxtorque Mini Cannulated Screw System

- Pathway: 510(k) (Special)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Dec 8, 2008 after 94 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000080 (2000). 8 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K060428: CSS Cannulated Screw System, Orthohelix Surgical Designs, Inc. (2006) Summary page 2.
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 2.
- K071092: Asnis Micro Cannulated Screw, Howmedica Osteonics Corp. (2007) Summary page 2.
- (no number) CSS Cannulated Screw System: named in the summary without a submission number

## Most influential descendants
- K131324: Maxtorque Screw System (2013), 2 descendants of its own
- K182989: AURORA™ Screw System (2018), 0 descendants of its own
- K150871: ForeFoot STP System (2015), 0 descendants of its own

## Recalls of this device
- Jan 29, 2010 · Class II · Z-0026-2013: The tips of the drivers are breaking while being used to drive the screws into patients.
- Jan 29, 2010 · Class II · Z-0027-2013: The tips of the drivers are breaking while being used to drive the screws into patients.
- Sep 3, 2009 · Not classified · Z-1430-2010: The epoxy is flaking off the drill bits and countersinks.

## Indications for use
The MaxTorqueT M Cannulated Screw System is indicated for use in long and small bone fracture fixation, which includes the following: * Fractures of the tarsals and metatarsals * Fractures of the olecranon, distal humerus * Fractures of the radius and ulna · Patellar fractures * Distal tibia and pilon fractures · Fractures of the fibula, medial malleolus, or calcis * Tarso-metatarsal and metatarsal-phalangeal Arthrodesis · Metatarsal and Phalangeal osteotomies · Osteochondritis dissecans * Ligament fixation · Other small fragment, cancellous bone fractures and osteotomies

Source page: https://510kreport.com/device/K082574
Methodology: https://510kreport.com/methodology