(141 days)
When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.
When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used 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 or retrolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when used with the integrated fixation screws, do not require use of supplemental fixation.
When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") 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) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.
This submission is intended to seek clearance for a product line extension to the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System"). The product line extension includes the Lanx SA standalone implant models with titanium components for additional fixation.
All devices in the Lanx Fusion System are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Fusion System has a hollowed out area to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws which are made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.
The additional models added to the product line have the same or similar intended use and indications, principles of operation and technological characteristics as the current Lanx Fusion System. The addition of titanium components for additional fixation, and indications for standalone lumbar interbody use, do not raise any new questions of safety or effectiveness. Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices.
Acceptance Criteria and Study for Lanx Fusion System
The Lanx Intervertebral Body/VBR Fusion System sought clearance for a product line extension, specifically for standalone implant models with titanium components. The study to prove the device meets acceptance criteria focused on demonstrating comparable mechanical properties to its predicate devices, thereby ensuring it did not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| ASTM F2077 (Static Compression) | Met acceptance criteria |
| ASTM F2077 (Dynamic Compression) | Met acceptance criteria |
| ASTM F2077 (Static Torsion) | Met acceptance criteria |
| ASTM F2267 (Subsidence) | Met acceptance criteria |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the sample size used for each individual test (e.g., number of devices tested for static compression). However, it implies that the testing was conducted on "the Lanx Fusion System" as a representative sample of the product line extension.
The data provenance is not mentioned. It is common for such mechanical testing to be conducted in a laboratory setting, but the country of origin or whether it was retrospective/prospective is not specified.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
Not applicable. This device clearance is based on mechanical performance data comparing the new device to predicate devices rather than clinical data requiring expert review of outcomes.
4. Adjudication Method (Test Set)
Not applicable, as the evaluation was based on objective mechanical testing results against established ASTM standards. No human adjudication of clinical outcomes or images was involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was conducted or mentioned, as the clearance was based on mechanical testing, not clinical performance with human readers.
6. Standalone Performance (Algorithm Only)
Not applicable. This is a medical implant, not an AI algorithm. The performance discussed is the mechanical performance of the physical device.
7. Type of Ground Truth Used
The "ground truth" for this product line extension was established by the performance criteria defined in recognized ASTM standards (ASTM F2077 and ASTM F2267) for intervertebral body fusion devices. These standards provide objective metrics for mechanical performance parameters like compression, torsion, and subsidence.
8. Sample Size for Training Set
Not applicable. As this is a mechanical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles and existing knowledge of materials and biomechanics, rather than statistical training on a data set.
9. How Ground Truth for Training Set Was Established
Not applicable. (See #8 above). The design and development of the device would rely on established engineering principles, material science knowledge, and potentially prior device performance data, rather than a "ground truth" derived from a training set.
§ 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.