# K131324: Maxtorque Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: May 31, 2013 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: 10 generations back to K962616 (1996). 72 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082574: Maxtorque Mini Cannulated Screw System, Orthohelix Surgical Designs, Inc. (2008) Summary page 1.
- K060428: CSS Cannulated Screw System, Orthohelix Surgical Designs, Inc. (2006) Summary page 1.
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 1.
- K071092: Asnis Micro Cannulated Screw, Howmedica Osteonics Corp. (2007) Summary page 1.
- K111994: Smith & Nephew Cannulated Screws and Washers, Smith & Nephew, Inc. (2011) Summary page 1.
- K080943: Synthes 4.5 MM and 6.5 MM Headless Compression Screws, Synthes (Usa) (2008) Summary page 1.

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

## Indications for use
The MaxTorque M Screw System is indicated for use in long and small bone fracture, fusion, and osteotomy fixation, which includes but is not limited to the following: - Fractures of the tarsal 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, os 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/K131324
Methodology: https://510kreport.com/methodology