(156 days)
AxSOS 3 Ti is intended for long bone fracture fixation Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- Non-unions and malunions
- Normal and osteopenic bone
- Osteotomies
- Periprosthetic fractures of the femur and proximal tibia.
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
- Periprosthetic fractures
- Diaphyseal and metaphyseal areas of long bones in pediatric patients
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
SPS Small Fragment Set The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following:
- One third tubular plate: fibula, metatarsals, metacarpals
- Fibular plate: fibula
- Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle
- Oblique T-plate: distal radius
- T-plate: distal radius, calcaneus, lateral clavicle
- Cloverleaf plate: proximal humerus, distal tibia
- Calcaneal plate: calcaneus
- Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.
SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, Tbuttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
The AxSOS 3 Ti system includes anatomically contoured monoaxial locking plates, as well as screws and blind screws. The plates have been designed with holes that can accommodate either locking or non-locking screws, and also include holes for suture and Kirshner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters. All implantable components come sterile and non-sterile.
The Basic Fragment Set is part of the Stryker Plating System. The Basic Fragment Set consists of plates and screws for fixation of fractures of the cortical and metaphyseal area of the long bone as well as fracture of the pelvis. The implant set is available in either in stainless steel (316 L) or titanium alloy (Ti6Al4V).
This submission is not intended to introduce any new implants into the system, but rather to demonstrate compatibility between the AxSOS 3 Ti system (K153379) and several of the titanium screw/plate components found in the Stryker Plating System (SPS) most recently cleared in K060798. The AxSOS 3 Ti plates and screws are manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and available sterile and non-sterile.
This document is a 510(k) premarket notification for a medical device called the "AxSOS 3 Ti; Stryker Plating System." As such, the purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria or conduct clinical trials in the way a PMA (Premarket Approval) submission would.
Therefore, the provided document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
Instead, the document focuses on:
- Indications for Use: Detailing what the device is intended for (e.g., long bone fracture fixation, specific types of fractures, different anatomical locations).
- Device Description: Explaining the components (plates, screws), materials (titanium alloy), and forms (sterile/non-sterile).
- Predicate Devices: Identifying previously cleared devices to which the current device is compared for substantial equivalence.
- Non-Clinical Testing: Mentioning "Bench testing and an engineering analysis" to demonstrate compatibility between components, and bacterial endotoxin testing for pyrogenicity.
- Absence of Clinical Testing: Explicitly stating that "Clinical testing was not required for this submission."
The "Conclusion" section reinforces that the submission is about demonstrating cross-compatibility between two existing systems (AxSOS 3 Ti and Stryker Plating System) based on bench testing and engineering analysis, rather than proving performance against specific acceptance criteria through extensive studies as typically understood in the context of AI/software device evaluation.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.