# K111891: Synthes Brainlab Trauma Compatible Instruments

- Pathway: 510(k) (Special)
- Applicant: Synthes (USA) Products, LLC
- Decided: Nov 28, 2011 after 146 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040336: Synthes (Usa) Lateral Entry Femoral Nail System, Synthes (Usa) (2004) Summary page 1.
- K961413: Synthes Anatomical Locking Plate System, Synthes (Usa) (1996) Summary page 3.
- K000066: Synthes (Usa) Locking Condylar Plate (LCP) System, Synthes (Usa) (2000) Summary page 1.
- K041911: Synthes (Usa) LCP Curved Plates, Synthes (Usa) (2004) Summary page 1.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 1.

## Indications for use
Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The Synthes Lateral Entry Femoral Nail System also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System Synthes ALPS System is a plate and screw system intended to treat fractures of various long bones including radius, ulna, humerus, tibia, fibula, and femur. The Synthes ALPS is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System Synthes LCP System is intended for buttressing multi-fragmentary distal femur fracture including supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non - unions and malunions. The Synthes LCP is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System. The Synthes Curved Broad Plates are intended for fixation of various long bone, such as the humerus, femur, and tibia. They are also for use in fixation of per-prosthetic fractures, osteopenic bone and non-unions or malunions. The Synthes Curved Broad Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma navigation system The Synthes Curved Condylar Plates are intended for buttressing multi fragmentary distal femur fractures, including: supracondylar, intra-articular and extra articular condylar fractures, peni-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malun ions, and osteotomies of the femur. The Synthes Curved Condylar Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System Synthes LCP Distal Femur Plates are intended for buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fracture and fractures in normal osteopenic bone, non-unions and malunions, and osteotomies of the femur. The Synthes LCP Distal Femur Plate is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System

Source page: https://510kreport.com/device/K111891
Methodology: https://510kreport.com/methodology