(102 days)
The OsteoMed Calcaneal Plate and Screw Fixation System Is Intended for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, ioint depression, tonque type and severely comminuted fractures. Plates and screws are intended for single use only.
The OsteoMed Calcaneal Plate and Screw Fixation System is comprised of various plates and screws. Plates are provided in a variety of arm configurations, in a variety of sizes in lengths of 45mm through 76mm and thickness of 1.0mm through 2.0mm. Screws to be provided in this system are 3.0mm and 3.5mm diameter in lengths of 18mm through 55mm with either standard or locking features. Plates are made of Titanium (ASTM F-67) or Titanium Alloy (ASTM F-136). The Screws are made of Titanium Alloy (ASTM F-136). Drill guides, pilot drills, depth gauge, drivers, bending pliers, plate cutters, guide wires and preparation instruments will also be a part of the system.
This document is a 510(k) Summary for the OsteoMed Calcaneal Plate and Screw Fixation System. It is a medical device submission seeking clearance from the FDA, not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, ground truth establishment, expert qualifications, and AI/ML specific evaluations (like MRMC studies) is not present in this document.
The document discusses substantial equivalence to predicate devices based on similarities in intended use, material, design, and operational principles, rather than performance against specific acceptance criteria.
Information that can be extracted from the provided text:
- Device Proprietary Name: OsteoMed Calcaneal Plate and Screw Fixation System
- Intended Use: Fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures.
- Predicate Devices: Synthes K991407, New Deal K041786, and Darco K061808.
- Basis for Equivalence: Similarities in intended use, material, design, and operational principle to the predicate devices.
- Conclusion: OsteoMed believes that the OsteoMed Calcaneal Plate and Screw Fixation System does not raise any new safety or effectiveness issues due to the similarity of materials and design to both pre-enactment and post-enactment devices.
§ 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.