# K040908: Ebi Distal Radius Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Jun 25, 2004 after 79 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 K000636 (2000). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000636: Stryker Trauma Plating System, Howmedica Osteonics Corp. (2000) Summary page 1.
- K002775: Distal Volar Radius Fracture Repair System, Hand Innovations, Inc. (2000) Summary page 1.

## Most influential descendants
- K093761: Optilock VL (Variable Angle Locking) Distal Radius Plating System (2010), 3 descendants of its own
- K150675: Dorsal Spanning Plate (2015), 1 descendant of its own
- K212601: DRPx Locking Distal Radius Plate System (2022), 0 descendants of its own
- K110271: Maestro Wrist Plating System (2011), 0 descendants of its own

## Indications for use
The EBI® Distal Radius Plating System is indicated for the fixation of fractures and osteotomies involving the distal radius.

Source page: https://510kreport.com/device/K040908
Methodology: https://510kreport.com/methodology