(29 days)
The Curved PEEK Tetris™ Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.
The Curved PEEK Tetris ™ may be implanted singularly or in pairs.
The supplemental internal fixation systems that may be used with the Curved PEEK Tetris™ Spinal Implant is the same as the Curved PEEK Tetris™ Spinal Implant and include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
The Curved PEEK Tetris® Spinal implant is a hollow, slightly curved frame with tapered edges. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies.
The frame is forged from PEEK (PEEK-OPTIMA™ LT1), which is radiolucent, and incorporates small Titanium alloy (TiAl6V4) marker pins so the device can be located within the body. The marker pins meet ASTM F-136 and ISO 5832/3.
The Curved PEEK Tetris™ Spinal Implant is available in a variety of sizes ranging from 7mm to 48mm. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition. The Curved PEEK Tetris™ may be implanted individually or in pairs.
The provided text is a 510(k) summary for the Curved PEEK Tetris™ Spinal Implant. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria through clinical trials or performance testing.
Therefore, the input does not contain information on acceptance criteria, a study that proves the device meets specific criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details.
The document primarily focuses on establishing substantial equivalence based on similarities in:
- Intended Use: Used to replace a vertebral body resected due to tumor or trauma/fracture in the thoracolumbar spine (T1 to L5), with supplemental internal fixation.
- Operating Principle: Not explicitly detailed beyond being a vertebral body replacement.
- Basic Design: Hollow, slightly curved frame with tapered edges, open upper and lower aspects, and walls featuring spikes for anchorage.
- Materials: PEEK (PEEK-OPTIMA™ LT1) with Titanium alloy (TiAl6V4) marker pins.
- Surgical Techniques and Equipment: Same as the predicate device.
- Supplemental Internal Fixation Systems: Same as the predicate device (e.g., DePuy AcroMed titanium plate or rod systems).
- Manufacturing Environment, Sterilization Process, and Packaging Configurations: Same as the predicate device.
Conclusion stated in the document: The Curved PEEK Tetris™ is substantially equivalent to the predicate device, PEEK Tetris™ (cleared under K031757), based on functional design, indication for use, principles of operation, materials, and performance characteristics.
Since the provided text does not contain the information requested in the prompt regarding acceptance criteria, studies, and data specific to performance validation, I cannot fill out the requested table or provide those details. The 510(k) process relies on demonstrating equivalence to an existing device, rather than providing new performance data against specific acceptance criteria for a novel device.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.