# K110895: Ortho Solutions Trauma Implants for Osteosynthesis

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Solutions Limited
- Decided: Dec 19, 2011 after 264 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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). 92 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961522: Kirschner Wire (K-Wire) and Steinmann Pin, Synvasive Technology, Inc. (1996) Summary page 1.
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 1.
- K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins, Treu-Instrumente GmbH (2009) Summary page 1.
- K031127: Orthopedic Wire, Howmedica Osteonics Corp. (2003) Summary page 1.
- K083490: Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685, Biopro, Inc. (2009) Summary page 1.
- K002125: Pins and Wires, Implant Resource, Inc. (2000) Summary page 1.
- K903261: Rush Pin, Onyx Medical Corp. (1990) Summary page 1.
- K092038: Aptus K-Wire System, Medartis AG (2009) Summary page 1.
- K925447: Oti Orthopedic Wire System, Osteo Technology, Inc. (1993) Summary page 1.
- K021233: Aap Cannulated Screws, Aap Implantate AG (2002) Summary page 1.
- K080101: Aap Cannulated Screw and Darco Headed Screw, Aap Implantate AG (2008) Summary page 1.
- K060156: Straight Plate with Angular Stability & Screw System, I.T.S. Implantat-Technologie-Systeme GmbH (2006) Summary page 1.
- K100359: Darco Headed Cannulated Screw, Wrightmedicaltechnologyinc (2010) Summary page 1.
- K102903: Pioneer Cannulated Screw System, Pioneer Surgical Technology, Inc. (2010) Summary page 1.
- K903810: Ace Cannulated Self Tapping Cancellous Bone Screw, Ace Medical Co. (1990) Summary page 1.
- K903811: Ace Cannulated Cortical Bone Screw, Ace Medical Co. (1990) Summary page 1.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.

## Most influential descendants
- K163489: OrthoSolutions 'System26' Bone Screws (2017), 3 descendants of its own
- K150889: Suture Wires and Wire Loops (2015), 2 descendants of its own
- K203773: BRM TOOL Screws (2022), 1 descendant of its own
- K151848: Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System (2016), 1 descendant of its own
- K261271: Cable-Ready® Cable Grip System (2026), 0 descendants of its own

## Indications for use
The intended use of the Ortho Solutions Trauma Implants for Osteosynthesis System is to draw two or more aligned bone fragments together to facilitate healing. Ortho Solutions K-Wires. Steinman Pins. Guide Pins Fixation Pins. & Rush Pins are indicated for use in fixation of bone fractures, for bone reconstruction, for skeletal traction in alignment of long bone fractured segments, and as guide pins & wires for insertion of other implants. Ortho Solutions Cerclape Wire is indicated for use for bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures where other treatments or devices have been unsuccessful, and bone reconstruction procedures. Ortho Solutions Cannulated Bone Screws and Washers are indicated for use over a guide pin or wire for aligned bone fracture fixation and bone fragment fixation. Washers of matching size to the cannulated bone screw may be used in certain applications. Cannulated bone screw sizes (with optional washer) of 4.0mm, 4.5mm, 5.0mm, 6.5mm, and 8.0mm are to be used with large and long bones in the skeletal anatomy. Specific indications, which are dependent in part on the diameter of the screw include: Minimally invasive fracture/joint reconstructions; Additive osteosynthesis for complex joint fractures; Multiple-fragment joint fractures; Femoral neck and femoral head fractures; Femoral supracondylar fractures; Tibial plateau fractures; Fractures of the head of the humerus & tibia; Cooper fractures of the tibia; Fractures of radius, wrist, ankle, elbow, and shoulder; Ligament fixation of the proximal humerus; Fractures of the acetabulum and dorsal pelvic ring; Condylar. fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Fractures of the calcaneus and talus; Arthrodesis of the ankle joint; and Avulsion fractures. The Ortho Solutions Trauma Implants for Osteosynthesis System is not intended for spinal use.

Source page: https://510kreport.com/device/K110895
Methodology: https://510kreport.com/methodology