# K060428: CSS Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Mar 7, 2006 after 14 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000080 (2000). 1 ancestor in all.
46 later devices descend from it; 4 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 1.

## Most influential descendants
- K124027: Monster Screw System (2013), 41 descendants of its own
- K151418: Monster Screw System (2015), 27 descendants of its own
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System (2017), 24 descendants of its own
- K153378: Monster BITE Screw System (2015), 22 descendants of its own
- K190586: Monster® Screw System (2019), 21 descendants of its own

## Recalls of this device
- Oct 15, 2010 · Not classified · Z-0466-2011: The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of 
- Oct 15, 2010 · Not classified · Z-0467-2011: The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of 
- Oct 15, 2010 · Not classified · Z-0468-2011: The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of 
- Apr 7, 2009 · Not classified · Z-1250-2010: A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw.

## Indications for use
The CSS Cannulated Screw System will be 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 humerous * Fractures of the radius and ulna * Patella 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/K060428
Methodology: https://510kreport.com/methodology