(72 days)
The Phantom® Hindfoot TTC/TC Nail system is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
- · Post-traumatic or degenerative arthritis
- · Previously infected arthrosis
- Revision of failed ankle arthrodesis
- · Revision of failed total ankle arthroplasty
- · Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
- · Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
- Rheumatoid arthritis
- · Osteoarthritis
- Nonunions or pseudarthrosis of hindfoot and distal tibia
- · Trauma (severe or malunited tibial pilon fracture)
- · Charcot foot (neuroarthropathy)
- · Severe end-stage degenerative arthritis
- Instability and skeletal defects after tumor resection
- · Pantalar arthrodesis
- · Severe foot/ankle deformity
The Paragon 28® Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes, lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.
The provided text is a 510(k) summary for the Phantom® Hindfoot TTC/TC Nail System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.
Therefore, the input text does not contain the information requested in the prompt regarding acceptance criteria and a study that proves the device meets them. This type of submission (510(k)) typically relies on comparisons to existing devices, and often does not require new clinical or extensive non-clinical studies to establish new performance metrics.
Specifically, the document states:
- "Non-clinical testing was not necessary to support equivalence. Engineering analyses were provided to support equivalence."
- "Clinical testing was not necessary to support equivalence."
This clearly indicates that no studies were performed to establish and meet acceptance criteria for device performance. The submission relies on the device having the "same intended use and technological characteristics as the predicate devices" to claim substantial equivalence.
§ 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.