(141 days)
The Medline UNITE® Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodesis, in conjunction with stabilization of fresh fractures, revision procedures, and reconstruction of bones in the feet and ankles.
The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® Ankle Fusion Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The system can be used in both adult and pediatric (adolescent and child) patients.
Medline UNITE® Ankle Fusion Plates and Screws used for the surgical treatment of pediatric patients should not cross an active growth plate as this may impede bone growth and development in skeletally immature patients. Implanted Medline UNITE® Ankle Fusion Plates and Screws which span an active growth plate in a pediatric patient. should be considered for hardware removal after primary arthrodesis or bone healing has been achieved.
The Medline UNITE® Ankle Fusion Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6A1-4V ELI). The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 4.5mm and 5.5mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates. Additionally, several plates in the system can accommodate 3.5mm and 4.0mm locking and non-locking cortical screws. Previously cleared 3.5mm (K151235) and 4.0mm locking and non-locking cortical screws, ranging from 16-40mm will be included in the tray with the Medline UNITE® Ankle Fusion Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drills, drill guides, tissue protectors, targeting guides, targeting guide sleeves, and a tray.
I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification for a medical device (Medline UNITE® Ankle Fusion Plating System) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical (bench) testing.
The document explicitly states:
- "This section does not apply. No animal testing was performed."
- "This section does not apply. No clinical testing was performed."
- "Summary of Clinical Testing: Not applicable."
Therefore, there is no information regarding:
- Acceptance criteria and reported device performance related to a clinical study.
- Sample size used for the test set or its data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.