(148 days)
The external fixation system is a device intended to be used in treatment of bone conditions including limb lengthening, osteotomies, the arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
The external fixation system includes various size components to accommodate various anatomies and injuries. The clamps enable the frame to be coupled to bone by securing the rods and Schanz Screws for the intended use. Components designed for this system are the medium clamp to accept the 8.0mm carbon fiber rod (100mm to 500mm length) and Schanz Screws (4.0mm diameter x 125mm length and 5.0mm diameter x 150mm to 200mm lengths), and the large clamp to accept the 11.0mm carbon fiber rod (100mm to 500mm length) and Schanz Screws (4.0mm diameter x 125mm length, 5.0mm diameter x 150mm length to 200mm lengths, and 6.0mm diameter x 225mm to 300mm lengths).
The provided 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices.
Therefore, the following information cannot be extracted from the provided text:
- Table of acceptance criteria and reported device performance: No performance criteria or results are mentioned.
- Sample size used for the test set and data provenance: No test set is described.
- Number of experts used to establish ground truth and their qualifications: Not applicable as no ground truth establishment is described.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: No training set is described.
- How the ground truth for the training set was established: Not applicable.
The document states that substantial equivalence is based on the device having the "same intended use, materials, and same technological characteristics as the predicate devices." It explicitly mentions:
"The external fixation system is substantially equivalent to the Technological Characteristics predicate devices with respect to the design, function, and Comparison: material."
And concludes:
"There are no significant differences between the external fixation system and the other devices as listed in the Substantially Equivalent Devices. The external fixation system and the predicate devices have similar design attributes, material, and intended use thus is considered substantially equivalent."
This type of 510(k) submission relies on demonstrating similarity to already legally marketed devices rather than presenting new performance data against specific acceptance criteria.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.