(21 days)
The VERTE-STACKTM Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). The VERTE-STACK™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.
The VERTE-STACK™ device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK™ device is fabricated and manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT) along with a tantalum marker. Alternatively the device may be manufactured from titanium alloy.
The design of the VERTE-STACK™ device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.
The VERTE-STACK™ device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.
The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK™ constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK™ constructs may not be used with stainless steel supplemental fixation devices.
The purpose of this submission is to include additional components to the previously cleared VERTE-STACK™ Spinal System.
This 510(k) summary (K041556) describes a conventional spinal implant system, the VERTE-STACK™ Spinal System. For this type of device, performance is typically assessed through substantial equivalence to predicate devices, mechanical testing, and biocompatibility, rather than clinical studies involving human readers or AI.
Therefore, the following information regarding acceptance criteria, study details, and expert involvement for AI/human reader performance studies is not applicable to this submission. The device's acceptance is based on its similarity to previously cleared devices (predicates) and its ability to meet established material and mechanical standards.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition | Based on Polyetheretherketone (PEEK OPTIMA LT) with a tantalum marker OR Titanium alloy. |
| Indications for Use (Substantial Equivalence) | Intended for vertebral body replacement in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). |
| Use with Supplemental Fixation | To be used with additional anterior and/or posterior spinal instrumentation to augment stability (e.g., Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, VANTAGE™ Anterior Fixation System, TSRH® System, CD HORIZON® Spinal System, GDLH® Spinal System, and/or their successors); PEEK constructs with stainless steel or titanium fixation; Titanium constructs NOT with stainless steel fixation. |
| Use with Bone Graft | Intended to be used with bone graft. |
| Design Characteristics | Stackable components of different sizes and heights to suit individual patient pathology and anatomical requirements. May be used individually or stacked. |
| Substantial Equivalence to Predicate Devices | Demonstrated substantial equivalence to previously cleared VERTE-STACK™ Spinal System components (K031780 and K040536). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device's clearance relied on substantial equivalence and non-clinical testing, not a test set of patient data for performance evaluation in the context of AI or human reading.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for clinical interpretation or AI performance was not established as part of this submission. The "ground truth" for this device relates to its material properties, mechanical integrity, and design features conforming to established standards for spinal implants.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication for clinical evaluations was mentioned in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical surgical implant, not a diagnostic or AI-assisted interpretation tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (spinal implant), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly referred to for this type of device includes:
- Engineering consensus and established industry standards for material strength, biocompatibility, and mechanical properties.
- Regulatory definitions and requirements for spinal intervertebral body fixation orthoses.
- Data supporting the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this device's evaluation is not based on machine learning.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.