(30 days)
Intended Use:
The intended use of the Tyber Medical Anatomical Plating System is to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Fraq System and Ankle Fracture/ Fusion System with the following indications:
Indications for Use:
Mini-fraq System
The Tyber Medical Mini-Fraq System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone including, but not limited to, the hand, wrist, foot, and ankle. The mini-frag system is also intended for reduction and stabilization of non-load bearing long bone fragments. The Tyber Medical Mini-frag System is not for Spinal Use.
Ankle Fracture/Fusion System
Tyber Medical Ankle Fracture/Fusion System is indicated for Use in:
Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, periarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;
- In intra- and extra articular fractures, osteotomies, medial malleolar fractures and nonunions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;
- In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle.
The Tyber Medical Ankle Fracture/Fusion Plating System is not for Spinal Use.
The systems presented in this Special 510(k) submission consist of various bone plates, locking screws, washers, and instruments. The Tyber Medical Anatomical Plating System consists of the following categories:
1.Mini-frag System
2.Ankle Fracture/Fusion System
A description of each system is provided below:
Mini-frag/Small Bone System
The Tyber Medical Mini-frag System is designed to address a variety of indications for short bones and sincluding, but not limited to, the hand, wrist, foot and ankle.
The System will incorporate both Locking Screws and standard non-locking Screws in 2.0, 2.5, and 4.0mm sizes in various lengths. Optional bone screw Washers are available for the non-locking Screws in 2.0mm sizes. All locking screws can be placed on-axis with the internal plate threads or up to 15 degrees off axis in any direction.
All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws and optional bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The instruments are not specific to the system. The Tyber Medical Mini-frag/Small Bone System is offered both sterile and non-sterile.
Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery.
The System will incorporate both locking Screws and standard non-locking screws in 2.7, 3.0, 3.5, and 4.0mm sizes in various lengths. Optional bone screw Washers are available for the non-locking Screws in 2.7, 3.5, and 4.0mm sizes. All locking screws can be placed onaxis with the internal plate threads or up to 15 degrees off axis in any direction.
All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws and optional screw washers are composed of Ti-6AI-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary Instrumentation) is available with the system. The instruments are not specific to the system.
The Tyber Medical Ankle Fracture/Fusion System is offered both sterile and non-sterile.
The provided text is a 510(k) Summary for the Tyber Medical Anatomical Plating System and does not contain the detailed information required for the questions regarding acceptance criteria and study particulars for a software-based medical device.
The document describes a medical device, which appears to be metallic bone fixation appliances and accessories (plates, screws, and washers). The submission is a Special 510(k), indicating a change to an existing cleared device, specifically the addition of optional bone screw washers to be used with non-locking screws in the Mini-fraq and Ankle Fracture/Fusion Systems.
Since this is a hardware device (bone fixation system) and the submission focuses on the addition of a physical component (washers), the request for details typically associated with software device evaluations (like test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.
The document does mention "All design control activities, including verification, and other testing, demonstrates that adding optional screw Washers to the Tyber Medical Anatomical Plating System does not raise any questions of safety or performance and is substantially equivalent to the predicate device(s)." However, it does not elaborate on the specific acceptance criteria or the studies performed. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section is a general statement about design control activities.
Therefore, I cannot provide the requested information based on the given text.
§ 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.