# K021579: Magly 4.0 and 5.5 MM Locking System

- Pathway: 510(k) (Traditional)
- Applicant: Magly Orthopedics, LLC
- Decided: Aug 9, 2002 after 87 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Synthes 4.0 and 5.0mm Locking Screws: named in the summary without a submission number

## Indications for use
Magly 4.0 and 5.5mm Locking screws are used for the interlocking of APEX Intramedullary Femoral and Tibial Nails

Source page: https://510kreport.com/device/K021579
Methodology: https://510kreport.com/methodology