(171 days)
The Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s).
The Altus Spine Interbody Fusion is to be combined with cleared supplemental fixation systems.
The Altus Spine Titanium Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The Altus Spine Titanium Interbody Fusion System implants are made of PEEK with Tatalum conforming to ASTM F2026 and ASTM F560 and Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The Altus Spine Titanium Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.
The provided document is a 510(k) premarket notification letter from the FDA for the "Altus Spine Interbody Fusion System." This letter and the accompanying 510(k) summary pertain to a medical device (an intervertebral body fusion device) and not an AI or software as a medical device (SaMD). Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:
- Indications for Use: The system is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at specific spinal levels (L2-S1), requiring six months of non-operative treatment, and may include patients with previous non-fusion surgery or Grade 1 spondylolisthesis. It must be combined with cleared supplemental fixation systems.
- Technological Characteristics: The purpose of this submission is to include PEEK and Titanium alloy intervertebral body fusion devices into the existing Altus Spine Interbody Fusion System family. The core design and fundamental technology remain the same as the predicate devices, with only minor dimensional changes.
- Non-Clinical Tests: Engineering analysis was presented to demonstrate that the revised system does not present a new worst-case performance and is substantially equivalent to the predicates. This typically involves mechanical testing (e.g., static and dynamic compression, torsion) to show the device meets established performance standards for interbody fusion devices, but specific details of these tests or their acceptance criteria are not provided in this summary.
In summary, as this is a medical device clearance based on substantial equivalence, the type of information requested (AI/SaMD-specific details) is not present in this document.
§ 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.