(119 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 of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion 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 nonoperative 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 The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be level(s). combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System.
When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from TI to LS) 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
All devices in the Lanx Fusion System are made of PEEK (OPTIMA®) per ASTM F2026 and Titanium alloy (Ti-6Al-4V) per ASTM F136. The Fusion System has a hollowed out area to accommodate autogenous bone graft, and transverse grooves to improve fixation and stability. 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 Lanx Fusion System, a medical device for spinal fusion and vertebral body replacement, obtained 510(k) clearance (K083815) based on mechanical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: Meets standards specified in ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Device Static and Dynamic Planar Shear and Torsion Testing) and ASTM F2267 (Standard Test Method for Measuring Load Bearing Characteristics of Spinal Implants in a Vertebrectomy Model). | "In all instances, the Lanx Fusion System met acceptance criteria and functioned as intended." (Page 3 of 5, K083815) The submission indicates mechanical properties were "comparable to the predicate device." |
| Material Composition: All devices made of PEEK (OPTIMA®) per ASTM F2026 and Titanium alloy (Ti-6Al-4V) per ASTM F136. | The device description explicitly states: "All devices in the Lanx Fusion System are made of PEEK (OPTIMA®) per ASTM F2026 and Titanium alloy (Ti-6Al-4V) per ASTM F136." (Page 2 of 5, K083815) |
| Intended Use/Indications: Should have the same intended use and indications as the current Lanx Fusion System and predicate devices. | The submission states: "The additional devices added to the product line have the same intended use and indications, principles of operation, and technological characteristics as the current Lanx Fusion System." (Page 2 of 5, K083815) |
| Safety and Effectiveness: Do not raise new questions of safety or effectiveness compared to predicate devices. | "The minor difference between the current devices and the devices added to the product line, addition of titanium material, do not raise any new questions of safety or effectiveness." (Page 2 of 5, K083815) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document refers to mechanical performance testing per ASTM F2077 and ASTM F2267. These are standard test methods for evaluating medical devices. The document does not specify the exact sample size (number of devices tested) for these mechanical tests, nor does it provide information about data provenance (e.g., country of origin, retrospective/prospective) for clinical or patient data, as this device's clearance was based on demonstrating substantial equivalence through engineering and mechanical testing, not new clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device's clearance was based on mechanical testing and comparison to predicate devices, not on expert-adjudicated ground truth derived from clinical cases or images.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on mechanical equivalence to predicate devices, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI or software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance was:
- Engineering Standards: Compliance with established ASTM standards (F2077, F2267 for mechanical properties; F2026, F136 for materials).
- Predicate Device Performance: The mechanical characteristics of the new device were compared and found "comparable" to existing cleared predicate devices.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The development process would involve iterative design and testing, but not in the sense of a data "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.