# K061098: Ebi Optilock Periarticular Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: May 24, 2006 after 35 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
No predicates in its family tree.
57 later devices descend from it; 3 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EBI® Periarticular Plating System: named in the summary without a submission number

## Most influential descendants
- K113048: Maxlock Extreme System (2012), 52 descendants of its own
- K122005: Maxlock Extreme System (2012), 39 descendants of its own
- K123203: Maxlock Extreme System Model MXL (2012), 38 descendants of its own
- K132591: Maxlock Extreme System (2013), 32 descendants of its own
- K153379: AxSOS 3Ti (2016), 25 descendants of its own

## Indications for use
The EBI® OptiLock® Periarticular Plating System (The System) is indicated for the fixation of fractures and osteotomies involving the femur or tibia. The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and nonunions and malunions. The System is intended for the treatment of nonunions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures. The System is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft. The System is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

Source page: https://510kreport.com/device/K061098
Methodology: https://510kreport.com/methodology