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510(k) Data Aggregation
(101 days)
LANX FUSION SYSTEM- SA
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 grafi 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 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 implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplemental fixation. The Lanx Lateral-SA implants are to be used with 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. TI- L5) for partial replacement (i.e., partial vertebrectonv) 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.
The purpose of this 510(k) submission is to include additional PEEK spacer and titanium screw fixation configurations to the Lanx SA System. The new Lanx Lateral-SA system has the same intended use, principles of operation, and technological characteristics as the current Lanx SA svstem.
The Lanx Lateral-SA System devices are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6AI-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-6AI-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 Lateral-SA System is provided non-sterile.
The Lanx Lateral-SA System is a medical device intended for spinal fusion procedures and vertebral body replacement. The acceptance criteria and supporting study details are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | ASTM F2077 (Static Compression) | Not explicitly stated, but implied to meet or exceed predicate device performance. | "Modified device met or exceeded predicate device performance." |
| Mechanical Performance | ASTM F2077 (Dynamic Compression) | Not explicitly stated, but implied to meet or exceed predicate device performance. | "Modified device met or exceeded predicate device performance." |
| Mechanical Performance | ASTM F2077 (Static Torsion) | Not explicitly stated, but implied to meet or exceed predicate device performance. | "Modified device met or exceeded predicate device performance." |
| Subsidence Resistance | ASTM F2267 (Subsidence) | Not explicitly stated, but implied to meet or exceed predicate device performance. | "Modified device met or exceeded predicate device performance." |
| Wear Debris | ASTM F1877 (Wear Debris) | Not explicitly stated, but implied to meet or exceed predicate device performance. | "Modified device met or exceeded predicate device performance." |
| Overall Equivalence | Substantial Equivalence to Predicate Device (K102738) | Demonstrate comparable safety and effectiveness to the predicate device. | "The minor differences in the new components do not raise any new issues of safety or effectiveness. Performance data presented also demonstrated comparable properties to the previously cleared Lanx SA system devices. Thus, the modified device has been shown to be substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes performance testing and engineering analysis to demonstrate substantial equivalence. It does not provide specific sample sizes (e.g., number of devices tested) for the ASTM tests mentioned (F2077, F2267, F1877). These tests typically involve a defined number of samples to ensure statistical validity, but the exact count is not disclosed in this summary.
The data provenance is laboratory-based engineering testing, rather than clinical data from human subjects. The report does not mention any country of origin for the data beyond being submitted to the FDA in the US, nor does it specify if the testing itself was retrospective or prospective in a clinical sense. It's prospective in the context of device development.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This submission relies on engineering and performance testing against established ASTM standards, not on expert interpretation of medical images or patient outcomes. Therefore, there's no "ground truth" in the sense of expert consensus on clinical findings.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
Not applicable. There was no clinical study involving human readers or interpretation requiring adjudication. Performance was evaluated against objective engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This document does not describe an MRMC study or any study involving human readers with or without AI assistance. The submission focuses on the mechanical and material equivalence of the device to its predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (spinal implant), not a software algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant here.
7. The Type of Ground Truth Used:
The ground truth for the performance claim is based on established engineering standards (ASTM F2077, ASTM F2267, ASTM F1877) and a comparison to the mechanical properties of a predicate device (K102738). The "ground truth" is that the device must meet or exceed the performance of the predicate device under these standardized conditions.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As described above, there is no "training set" in the context of this device's evaluation.
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