(30 days)
The BIOFOAM® Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
· Opening wedge osteotomies of Hallux Valgus
· Evans lengthening osteotomies
· Metatarsal/cuneiform arthrodesis
This device is intended for use with ancillary fixation.
The BIOFOAM® Bone Wedge is not intended for use in the spine.
The BIOFOAM® Bone Wedge is a titanium metal foam wedge used for angular correction of small bones in the ankle and foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.
This document is a 510(k) summary for the BIOFOAM® Bone Wedge, which is a medical device for internal bone fixation. It is a premarket notification to demonstrate substantial equivalence to a predicate device, not a study proving device performance against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.
The document primarily focuses on:
- Intended Use: What the device is meant to treat (bone fractures, fusions, or osteotomies in the ankle and foot).
- Device Description: What the device is (a titanium metal foam wedge).
- Substantial Equivalence: The core argument of a 510(k) submission, stating that the device is as safe and effective as a legally marketed predicate device, without detailing specific performance data or clinical studies in this summary.
Therefore, I cannot populate the table or answer the specific questions because the provided text does not contain the type of performance study data or acceptance criteria typically associated with a clinical trial or performance validation study.
§ 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.