# K042237: Ebi Periarticular Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Sep 16, 2004 after 29 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982222 (1998). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000066: Synthes (Usa) Locking Condylar Plate (LCP) System, Synthes (Usa) (2000) Summary page 1.
- K010766: Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate, Synthes (Usa) (2001)
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001)
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001)

## Most influential descendants
- K092078: Optilock Periarticular Plating (2009), 2 descendants of its own
- K140018: TSP Hip Fracture Plating System (2014), 1 descendant of its own
- K173826: THP Hip Fracture Plating System (2018), 0 descendants of its own

## Recalls of this device
- Apr 2, 2009 · Not classified · Z-2292-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2298-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2293-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2294-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2296-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2297-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2299-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2295-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2291-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2290-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

## Indications for use
The EBI® Periarticular Plating System is indicated for fixation of fractures and osteotomies involving the femur or tibia. The System consists of the following plate configurations: Distal Femoral Plate The Distal Femoral Plate 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. Proximal Lateral Tibial Plate The Proximal Lateral Tibial Plate 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. Proximal Medial Tibial Plate The Proximal Medial Tibial Plate 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. Distal Tibia Plate The Distal Tibial Plate 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/K042237
Methodology: https://510kreport.com/methodology