# K062494: Ebi Optilock Upper Extremity Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Oct 19, 2006 after 55 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000684 (2000). 5 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 28 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.
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001)
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 1.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 1.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 1.

## Most influential descendants
- K153716: GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. (2016), 15 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own

## Recalls of this device
- Mar 15, 2012 · Not classified · Z-1439-2012: Biomet initiated this action after a complaint was received that item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm.

## Indications for use
The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K062494
Methodology: https://510kreport.com/methodology