# K163489: OrthoSolutions 'System26' Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Solutions UK Limited
- Decided: Mar 8, 2017 after 86 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962616 (1996). 200 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110895: Ortho Solutions Trauma Implants for Osteosynthesis, Ortho Solutions Limited (2011) Summary page 4.
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis, Ortho Solutions Limited (2012) Summary page 4.
- K991197: Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24, Vilex, Inc. (1999) Summary page 4.
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 4.
- K150693: PHIN-FX Cannulated Lag Screw System, Ascent Medical, LLC (2015) Summary page 4.
- K131722: I.T.S. Extremity Fixation Systems, I.T.S. GmbH (2013) Summary page 4.

## Most influential descendants
- K203773: BRM TOOL Screws (2022), 1 descendant of its own
- K231649: Intraosseous Fusion Device System (2023), 0 descendants of its own
- K222820: BRM TOOL Screws, BIOPLAN Subtalar Implant (2022), 0 descendants of its own

## Recalls of this device
- Oct 10, 2017 · Class II · Z-0967-2018: Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot a

## Indications for use
The OrthoSolutions ‘System26’ cannulated screws (headed and headless compression) and washers are indicated for use over a guide pin or wire for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw. Washers of matching size to the headed cannulated bone screw may be used in certain applications for deficient osteopenic bone. The non-cannulated 2.0 (headed, headless compression and Twist-Off) bone screws are applicable, as well, for bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw. ‘System26’ non-cannulated 2.0mm (headed, headless compression and Twist-Off) bone screws and cannulated (headed and headless compression) bone screw sizes of 2.0mm, 2.5mm 3.0mm are indicated for treating small bone fractures as well as performing osteotomies, arthrodesis and joining cancellous bone fragments in the upper and lower limb and extremities. ‘System26’ cannulated bone screw sizes (headless compression and headed with optional matching washer) of 4.0mm, 5.0mm, 6.5mm, and 8.0mm are indicated to be used with large and long bones. Specific indications, which are dependent in part on the diameter of the screw include: Minimally invasive bone 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; Fractures of the tibia; Cooper fractures of the tibia; Bone fractures of the radius, wrist, ankle, elbow, and shoulder; Ligament fixation of the proximal humerus; Bone fractures of the acetabulum and dorsal pelvic ring; Condylar fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Bone fractures of the calcaneus and talus; Arthrodesis of the ankle joint; Arthrodesis of foot joints and; Avulsion fractures. The OrthoSolutions 'System26' Bone Screws are not intended for spinal use.

Source page: https://510kreport.com/device/K163489
Methodology: https://510kreport.com/methodology