(90 days)
The Endius Spinal Fixation System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are the thoracic, lumbar, and sacral spine.
The Endius Spinal Fixation System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Endius Spinal Fixation System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is obtained. Levels of fixation are L3-S1.
In addition, the Endius Spinal Fixation System, when not used with pedicle screws, is indicated for posterior hook and sacral screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previously failed fusion surgery.
The Endius Spinal Fixation System is a system that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, plates, and accessory connection components.
The provided text describes the Endius Spinal Fixation System and its substantial equivalence to a predicate device, the TriFix Spinal System. The evidence for meeting acceptance criteria primarily relies on biomechanical test results and comparison to the predicate device.
Here's a breakdown based on the information provided:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical Testing Compliance | Complies with ASTM F1717 |
| Indications for Use | Matches the predicate device (TriFix Spinal System) |
| Materials | Titanium (Predicate uses Stainless Steel or Titanium) |
| Product Labeling | Instructions for use and box labeling including all necessary warning statements (Identical to predicate) |
| Packaging/Sterilization | Non-sterile, single use only (Identical to predicate) |
Note: The FDA's substantial equivalence determination implies that the Endius Spinal Fixation System performs as safely and effectively as the legally marketed predicate device for its intended use. The primary 'study' presented is the comparison to the predicate and the biomechanical testing.
Study Details for Demonstrating Acceptance Criteria
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated for the biomechanical tests.
- Data Provenance: Not explicitly stated for specific test samples. However, the study involved a comparison against a predicate device, the TriFix Spinal System, also manufactured by Endius, Inc. The biomechanical testing compliance to ASTM F1717 refers to a standardized test, not a clinical trial withpatient data from specific countries.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable in the context of this submission. The "ground truth" for the device's performance in this filing is established through compliance with an industry standard (ASTM F1717) for biomechanical testing and comparison to a legally marketed predicate device. Clinical experts are not mentioned as being involved in establishing ground truth for the device's technical specifications or performance as required in this 510(k) summary.
4. Adjudication Method
- Adjudication Method: Not applicable. This submission relies on standardized testing and direct comparison to a predicate device, not on expert adjudication of clinical outcomes or images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed for this device as described in the provided text. This device is a spinal fixation system, not an AI/imaging diagnostic tool where such studies are common.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No, a standalone (algorithm only) performance study was not mentioned or performed. This device is a physical medical implant, not a software algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for demonstrating the device's meeting of acceptance criteria is based on:
- Biomechanical Test Results: Compliance with the ASTM F1717 standard for spinal implant constructs.
- Predicate Device Comparison: The established safety and effectiveness of the legally marketed TriFix Spinal System.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This filing does not describe a machine learning or AI-based device that would require a 'training set.'
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.