# K093983: Smple Plate  and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Trauma (Aka Ebi, Lp)
- Decided: Mar 19, 2010 after 85 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: 8 generations back to K962616 (1996). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 2.
- K083286: Orthopediatrics Pediloc Locking Plate System, OrthoPediatrics Corp. (2009) Summary page 2.
- K020221: Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment Set, Iql Mini Fragment Set, Biomet Orthopedics, Inc. (2002) Summary page 2.
- K061098: Ebi Optilock Periarticular Plating System, Ebi, L.P. (2006) Summary page 2.

## Indications for use
The SMPle™ Pediatric Submuscular Plating System is intended for adult or pediatric patients as indicated for long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, malunions, non-union or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, and radius. In pediatric femoral applications, the SMPle™ Pediatric Submuscular Plating System is intended for use in the treatment of femoral fractures, malunions or non-unions, femoral osteotomies required for the correction of deformity, and arthrodesis. Indications for buttressing multi-fragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.

Source page: https://510kreport.com/device/K093983
Methodology: https://510kreport.com/methodology