# K060294: Diaphyseal Plate

- Pathway: 510(k) (Traditional)
- Applicant: Hand Innovations, LLC
- Decided: Mar 22, 2006 after 44 days
- Product code: HRS (Plate, Fixation, Bone)
- 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 K000684 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.

## Most influential descendants
- K111663: Trauma Internal Fixation Systems (2012), 1 descendant of its own
- K243761: A.L.P.S. Small Fragment Plating System (2025), 0 descendants of its own

## Indications for use
The Diaphyseal Plate is intended for the fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K060294
Methodology: https://510kreport.com/methodology