# K092078: Optilock Periarticular Plating

- Pathway: 510(k) (Special)
- Applicant: Biomet Trauma
- Decided: Aug 5, 2009 after 27 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: 3 generations back to K982222 (1998). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061098: Ebi Optilock Periarticular Plating System, Ebi, L.P. (2006) Summary page 1.
- K042237: Ebi Periarticular Plating System, Ebi, L.P. (2004) Summary page 1.

## Most influential descendants
- K140018: TSP Hip Fracture Plating System (2014), 1 descendant of its own
- K173826: THP Hip Fracture Plating System (2018), 0 descendants of its own

## Indications for use
The EBI OptiLock Periarticular Plating System (The System) is indicated for 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 non-unions, 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 for 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/K092078
Methodology: https://510kreport.com/methodology