(63 days)
Fixation of fractures of the proximal humerus. The device is a single use implant.
The Atlas Fracture Proximal Humeral Nail is a modular intramedullary rod. The proximal piece is a solid cylinder with multiple screw holes. Screw holes are placed in such a way to allow the surgeon options in reconstruction of the fracture fragments. Depending on the nature of the fracture, the humeral head, for example, may be fixed by a screw placed perpendicular to the nail, or an upward angle. If the tuberosities need to be reattached, holes placed 45 degree with respect to the holes used for head reattachment. Additionally, suture holes are provided for soft tissue reattachment.
The distal piece is a cylindrically shaped solid intramedullary stem tapered at the tip to conform to the natural humeral geometry. The stem is fluted to provide rotational stability at insertion. Longer stem lengths (less than or equal to 175mm) are available with three distal screw holes, in different planes, allow additional screw placement. Holes are sized larger than the screws to allow for clearance. Distal stems with screw holes are provided with a polyethylene plug friction fit into the screw holes. These are simply pushed out by the surgeon for the holes to be used. All lengths are available without screw holes. The proximal piece and distal stems attach by means of screw threads.
The provided text is a K971816 FDA 510(k) submission for the Atlas® Fracture Proximal Humeral Nail. This document primarily describes the device, its intended use, potential risks, and establishes substantial equivalence to other legally marketed devices.
Based on the information provided in this document, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria in the way requested. This document does not contain:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance, number of experts, adjudication methods, or ground truth for any test or training sets.
- Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
The 510(k) process for this type of medical device generally focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring extensive clinical trials or performance studies akin to those for AI/Software as a Medical Device (SaMD). The substantial equivalence claim is based on the device's design, materials, and intended use being similar to existing devices.
Therefore, the requested information elements (1-9) are not present within this 510(k) submission.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.