(8 days)
The Hoffmann ® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
- Bone fracture fixation .
- . Osteotomy
- Arthrodesis .
- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful .
- Non-unions and delayed unions .
- Compression/distraction and lengthening .
This line extension is to modify the lengthener components to the Hoffmann® II Micro™ External Fixation System. This component is an external fixation frame component and can be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® II Micro " External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact" External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax "External Fixation System.
This document is a 510(k) premarket notification for a medical device called the "Hoffmann® II Micro™ Lengthener Line Extension." It does not contain information about acceptance criteria or a study proving the device meets those criteria.
Instead, the document details:
- The device's proprietary and common name.
- Its classification and product code.
- Contact information for the manufacturer.
- A brief description of the device as a line extension to modify lengthener components for external fixation systems.
- The intended use of the Hoffmann® II Micro™ External Fixation System, which includes stabilization of fractures, osteotomy, arthrodesis, correction of deformity, revision procedures, non-unions, delayed unions, and compression/distraction and lengthening.
- A statement of substantial equivalence to predicate devices based on intended use, materials, design, and mechanical performance.
- A letter from the FDA confirming the 510(k) clearance based on substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from the provided text. This type of submission relies on demonstrating similarity to existing, legally marketed devices rather than presenting new performance data against specific acceptance criteria.
§ 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.