# K021662: Magly 6.5MM Cannulated Screws

- Pathway: 510(k) (Traditional)
- Applicant: Magly Orthopedics, LLC
- Decided: Aug 12, 2002 after 84 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy/ACE 6.5mm Titanium Cannulated Cancellous Screws: named in the summary without a submission number

## Most influential descendants
- K030619: Odi 7.0MM Cannulated Screw System (2003), 0 descendants of its own

## Indications for use
Femoral neck fractures Metaphyseal fractures of the distal femur and tibia Fractures of the tibial plateau Fractures of the humerus, olecranon process, scapuls, and os calcis Fractures of the sacrum, acetabulum, and pelvic ring Fixation of the ileo-sacral joint Fusions of the foot and ankle

Source page: https://510kreport.com/device/K021662
Methodology: https://510kreport.com/methodology