# K151021: OsteoMed Cannulated Screw System

- Pathway: 510(k) (Special)
- Applicant: Osteomed Corp.
- Decided: Jul 15, 2015 after 90 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
Longest line of descent: 3 generations back to K013888 (2002). 6 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062863: Osteomed Extended 2.0/2.4CANNULATED Screw System, Osteomed LP (2006) Summary page 4.

## Most influential descendants
- K153338: Tiger Cannulated Screw System (2016), 7 descendants of its own
- K203595: DynaFuse Fixation System (2022), 5 descendants of its own
- K163303: OsteoMed ExtremiFix Mid and Large Screw System (2017), 3 descendants of its own
- K254110: DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (2026), 1 descendant of its own
- K233567: OsteoCoil™ Nitinol Compression System (Multiple Component PNs) (2024), 1 descendant of its own

## Indications for use
The OsteoMed Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.

Source page: https://510kreport.com/device/K151021
Methodology: https://510kreport.com/methodology