(81 days)
Magnum+ is a stand alone device intended to be used with bone screws. If the physician chooses to use fewer than the maximum number of screws accommodated by the device, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability.
When used as a vertebral body replacement:
When used as a vertebral body replacement, the device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
The interior of the spacer can be packed with allograft or autograft.
When used as an intervertebral body fusion device:
Lucent Magnum+ is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
Spinal Elements' Lucent Magnum+ device is composed of a main device body (spacer) and fixation screws. The spacer is generally oval-shaped with various holes throughout its geometry. The superior and inferior surfaces of the spacer have engagement members to help prevent migration once surgically positioned. The spacer has holes through it that allow for the passage of bone screws that affix to bone to help prevent migration.
Devices are available in a multitude of sizes. The spacer may be made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3 or polyetheretherketone (PEEK-OPTIMA LTI, provided by Invibio) conforming to ASTM F 2026. Because PEEK is radiolucent, tantalum (per ASTM F 560) pins are embedded into PEEK spacers to serve as markers for radiographic visualization of spacer orientation. Screws are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3. All implants are intended for single use only and should not be reused under any circumstances. Components from this system should not be used in conjunction with components from other systems.
This document is a 510(k) Premarket Notification for a medical device called Lucent® Magnum+. It describes the device, its intended uses, and claims substantial equivalence to previously cleared devices.
There is no information in this document about acceptance criteria, device performance metrics, or a study to prove the device meets acceptance criteria.
The document is a regulatory submission for premarket clearance, which typically focuses on demonstrating equivalence to existing legally marketed devices rather than presenting detailed performance studies against specific acceptance criteria for a novel AI device. The device itself is a physical intervertebral body fusion device and not an AI/ML powered device. Therefore, a study proving device performance against acceptance criteria as might be done for software or AI medical devices is not applicable here.
§ 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.