# K020562: Apex Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Magly Orthopedics, LLC
- Decided: May 16, 2002 after 85 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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) Stryker Howmedica Osteonics Retrograde/Antegrade Femoral Nail: named in the summary without a submission number
- (no number) ACE AIM Titanium Nails (DePuy/ACE, a Johnson & Johnson Company): named in the summary without a submission number
- (no number) Smith & Nephew TriGen Knee Nail: named in the summary without a submission number

## Indications for use
Low subtrochanteric fractures Pseudarthrosis and corrective osteotomies Transverse fractures Pathologic fractures, impending pathologic fractures, and tumor resections. Oblique and spiral fractures Supracondylar fractures, including those with intra-articular extension Segmental fractures Ipsilateral femoral neck fractures Comminuted fractures Fractures proximal to total knee arthoplasty Fractures with bone loss Fractures distal to a hip implant Nonunions and malunions. Acute bone lengthening and shortening Reamed- and unreamed applications High Supracondylar fractures, including those with intra-articular extension.

Source page: https://510kreport.com/device/K020562
Methodology: https://510kreport.com/methodology