(37 days)
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion.
The purpose of this submission is to introduce an additional cage size to the range of available Tritanium TL cages. The dimensions of the subject device are identical to the predicate TL cages (12mm width; 32mm length) but with a height of 8-10mm (based on expansion). The current range of Tritanium TL cages currently range in heights from 9-13mm.
The subject Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are hydraulically expandable interbody fusion devices. The subject device shares technological characteristics with the cited predicate devices and do not raise any new questions of safety and effectiveness. The below characteristics are shared between the subject and predicate devices:
• Graft windows for packing autogenous or allogenic bone
• Serrations on the superior and inferior surfaces
• Indicated for use with supplemental fixation
• Expandable in-situ
There are no changes to the fundamental technological characteristics of the identified predicate devices in this submission.
This document is a 510(k) summary for the Tritanium® X TL Expandable Curved Posterior Lumbar Cage. It describes the device and its intended use, and importantly, references a study to demonstrate its substantial equivalence to a predicate device.
Here's an breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document summarizes the performance testing conducted, but it does not explicitly state specific acceptance criteria values. Instead, it indicates that a "risk review was conducted on existing verification and validation data for the Tritanium X system relative to the addition of the 8mm implant," and concludes that "there would be no impacts to safety or effectiveness of the system by including this device." The mechanical tests performed are listed as:
| Acceptance Criteria (Not explicitly stated with numerical values in the provided text, but implied by regulatory standards for interbody fusion devices) | Reported Device Performance |
|---|---|
| Mechanical Performance (e.g., strength, stability, resilience under various loads as per relevant ASTM standards for intervertebral body fusion devices) | Subsidence testing: Conducted per ASTM F2267-04(2018). (Specific results not detailed, but implied to meet requirements for substantial equivalence.) |
| Impaction testing: Performed. (Specific results not detailed, but implied to meet requirements for substantial equivalence.) | |
| Safety and Effectiveness (Ensuring the additional implant size does not negatively impact the overall system's safety or effectiveness compared to the predicate) | A risk review was conducted which indicated "no impacts to safety or effectiveness of the system by including this device." The device is deemed substantially equivalent based on design, materials, feature comparisons, indications for use, and mechanical testing results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "existing verification and validation data" and "the addition of the 8mm implant" to the system. It's likely the "test set" refers to the specific 8mm implant size and its performance validation within the existing Tritanium X system, but the number of units or tests performed for this specific variant is not quantified.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a benchtop (mechanical) study, not a clinical study with human subject data. Therefore, the applicability of "retrospective or prospective" is not directly relevant in the clinical sense, but the testing itself would have been prospective to demonstrate the performance of the new size.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to the provided document. The study described is a mechanical performance study (subsidence and impaction testing) conducted on a medical device. It does not involve human readers, image interpretation, or the establishment of "ground truth" through expert consensus in a clinical or diagnostic context. The ground truth for mechanical testing is established by the specified ASTM standards and engineering principles.
4. Adjudication Method for the Test Set
Not applicable. As this is a mechanical performance study, there is no adjudication method in the sense of expert review or consensus for clinical data. The results are based on objective measurements from the mechanical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This document describes mechanical bench testing of an intervertebral body fusion device, not an AI or diagnostic imaging device that would typically undergo MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI or algorithm-based device. The term "standalone performance" typically refers to the performance of an AI model without human interaction.
7. The Type of Ground Truth Used
The "ground truth" for this study is based on established mechanical engineering standards (ASTM F2267-04(2018) for subsidence testing) and the mechanical properties derived from the impaction testing. The performance is assessed against these predefined engineering and material science criteria, which serve as the "ground truth" for device safety and effectiveness in a mechanical context.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.