# K120360: Ortho Solutions Trauma Plates for Osteosysnthesis

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Solutions Limited
- Decided: May 29, 2012 after 113 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 K962823 (1996). 59 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072411: Aap Bone Plates and Screw Implants, Aap Implantate AG (2008) Summary page 1.
- K102845: Mahe Fixation Plate and Screw System, Mahe Medical GmbH (2011) Summary page 1.
- K993289: Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System, Smith & Nephew, Inc. (1999) Summary page 1.
- K921786: Intramedullary Hip Screw, Smith & Nephew Richards, Inc. (1992) Summary page 1.
- K895241: Intramedullary Hip Screw, Richards Medical Co., Inc. (1990) Summary page 1.
- K946156: Depuy Compression Hip Screw System, Depuy, Inc. (1995) Summary page 1.
- K781762: Compression Hip Screw System, Howmedica Corp. (1978) Summary page 1.
- K071852: Aap Aps System, Aap Implantate AG (2007) Summary page 1.

## Most influential descendants
- K202764: Ortho Solutions Plating System (2020), 1 descendant of its own
- K210658: Volition Plating System (2021), 0 descendants of its own

## Indications for use
The intended use of the Ortho Solutions Trauma Plates for Osteosynthesis of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing. Ortho Solutions Bone Plates. Bone Screws, and Washers System is indicated for use in fixation of various fractured bones. Mini plates and screws 3.5mm or smaller are intended for use in small bones in the hand or foot and include the metacarpal, metatarsal, and phalange bones. Small and large plates and screws 4.0mm and larger are intended for use in large and long bones which can include the clavicle, scapula, pelvis, calcaneus, talus and long bones (humerus, ulna, radius, femur, tibia, and fibula) in the skeletal anatomy. Ortho Solutions Compression HiD Screw CHS/SCS System is indicated for fracture fixation in the proximal and distal regions of the human anatomy skeletal femur. Specific indications include: intracapsular fractures of the femoral neck; trochaneric and subtrochanteric neck fractures; osteotomies for patients with diseases or deformities of the hip;*hip arthrodesis; supracondylar fractures and distal femoral fractures. The Ortho Solutions Trauma Plates for Osteosynthesis is not intended for spinal use.

Source page: https://510kreport.com/device/K120360
Methodology: https://510kreport.com/methodology