# K030619: Odi 7.0MM Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Designs, Inc.
- Decided: Apr 1, 2003 after 33 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K893512 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990776: Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM, Aap Implantate AG (1999) Summary page 2.
- K014185: Aos Cannulated Bone Screw System, Advanced Orthopaedic Solutions, Inc. (2002)
- K893512: Depuy Cannulated Bone Screw, Depuy, Inc. (1989) Summary page 2.
- K021662: Magly 6.5MM Cannulated Screws, Magly Orthopedics, LLC (2002)
- (no number) AlDhatec Mfa.. Inc: named in the summary without a submission number

## Indications for use
The ODi 7.0mm Cannulated Screw System will be used on indications that are common with presently marketed cannulated screw systems. The primary indications are for fixation/stabilization of stable fractures of the proximal femur including pertrochanteric fractures, basilar femoral neck fractures, subcapital femoral fractures, and combinations of these fractures. Other indications include intercondylar femoral fractures and tibial plateau fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

Source page: https://510kreport.com/device/K030619
Methodology: https://510kreport.com/methodology