(87 days)
The NuVasive® CoRoent® Thoracolumbar System is indicated for intervertebral body fusion of the spine in sketally mature patients. The System is designed for use with autogenous and or allogeneic bone graft comprised of cancellous and or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of nonoperative treatment.
The NuVasive CoRoent Thoracolumbar System (XL platform) implants are intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the CoRoent Thoracolumbar System (XL and L platforms) implants are intended for use in the lumbar spine. from L1 to S1. for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc hemiation (with mvelopathy and or radiculopathy without axial pain). DDD is defined as back pain of discogence origin with degeneration of the disc confirmed by history and radiographic studies.
The Nu Vasive CoRoent Thoracolumbar System (XL and L platforms) can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
The subject NuVasive CoRoent Thoracolumbar System consists of devices manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3, and PEEK Optima LT-1 with titanium alloy or tantalum pins conforming to ASTM F136 or ASTM F1472 (tantalum markers conforming to ASTM 560 or ISO 13782). The implants are hollow devices with teeth on the endplate surfaces. The hollow core allows for the packing of autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to help promote a solid fusion. Small teeth on each end of the device serve to grip the adjacent vertebrae to resist migration of the device. The varying footprints are designed to address individual pathology and anatomic conditions of the patient, utilizing placement through various surgical approaches. The device is intended to be used with supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The subject implants are offered sterile and non-sterile with the accessory surgical instruments packaged as non-sterile to be sterilized by the end user.
The purpose of this 510(k) submission is to introduce titanium versions of the PEEK devices cleared in K161230 and add MR Conditional labeling.
The provided text is a 510(k) summary for the NuVasive® CoRoent® Thoracolumbar System, which is an intervertebral body fusion device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for a novel AI/software medical device.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for an AI-powered device.
The "Performance Data" section explicitly states: "Mechanical performance testing data was provided as part of the previous submissions to establish substantial equivalence for their use. The previously presented mechanical testing data are sufficient to support the addition of the titanium alloy implants to the subject system and does not warrant the need for additional nonclinical testing. Therefore, no new mechanical testing was performed for this 510(k) submission." It also mentions "an engineering rationale was provided for MR compatibility."
This indicates that the submission relies on previous mechanical testing for the predicate devices and engineering rationale for MR compatibility, rather than presenting a new study with explicit acceptance criteria and performance data for this specific 510(k). The device itself is a physical implant (titanium alloy and PEEK) and does not involve software or AI.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.