(117 days)
The APEX Spine System is 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. Iumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).
The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.
The APEX Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).
When used in a percutaneous, posterior approach with AIM Spine MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed prvious fusion in skeletally mature patients . Levels of fixation are for the thoracic. lumbar and sacral spine.
The purpose of this submission is to add cannulated screws to the APEX Spine System and add indications for use of the APEX Spine System in a posterior percutaneous approach and product code NKB. The APEX Spine System Cannulated Screws have exactly the same geometry of the APEX screws with the addition of a cannulation. The screws are available in a variety of diameters and lengths and can be used with the components of the previously cleared APEX Spine System.
Materials: Titanium alloy per ASTM F136
Function: The APEX Spine System is indicated for 1)non-cervical spinal fixation devices intended for posterior, non-pedicle fixation, 2)for non-cervical pedicle screw fixation and 3)hook fixation systems of the non-cervical spine, 4)for degenerative disc disease.
The APEX Spine System is a pedicle screw spinal system. The submission (K110906) addresses the addition of cannulated screws to the system and new indications for use in a posterior percutaneous approach.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Static Compression Bending
- Static Torsion
- Dynamic Compression Bending | Met: Results were "equal or higher than the predicate systems" for all tests (ASTM F1717-09). |
| Material Composition: - Titanium alloy per ASTM F136 | Met: The device utilizes Titanium alloy per ASTM F136. |
| Biocompatibility: (Implicitly covered by substantial equivalence to predicates) | Met: Substantially equivalent to predicate devices with established biocompatibility. |
| Sterility: - Non-sterile, steam sterilized at hospital | Met: Device is non-sterile and intended for steam sterilization at the hospital. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests. The document refers to "testing" and "results," implying a sufficient number of samples were tested to generate comparative data.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by the manufacturer or a contracted testing facility, following ASTM standards. This is a retrospective analysis in the context of device design and comparison to predicates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This submission focuses on the mechanical and material equivalence of a spinal implant system to predicate devices, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, this submission does not involve human readers or clinical interpretation that would require an adjudication method. The "adjudication" here is the comparison of mechanical test results against established predicate device performance and ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is not applicable to a spinal implant system focused on mechanical performance and material composition.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical spinal implant, not an AI algorithm.
7. The Type of Ground Truth Used
- Engineering/Performance Standards: The "ground truth" used for testing was primarily based on:
- ASTM F1717-09: "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
- Predicate Device Performance: The performance of previously cleared spinal systems (e.g., APEX Spine System (K062513), Viper Spine System (K090648), Polaris Spinal System (K103393), Synthes Pangea System (K052123)).
- Material Specifications: ASTM F136 for Titanium alloy.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this kinesiologic and material equivalence submission for a physical medical device. The device's design is based on established engineering principles and prior device knowledge, not a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant. The "ground truth" in development of such a device is rooted in biomechanical principles, material science, and the established safety and effectiveness of predicate devices.
Summary of the Study Proving Acceptance Criteria:
The study summarized in K110906 is a non-clinical bench testing study designed to demonstrate the substantial equivalence of the modified APEX Spine System (with added cannulated screws and percutaneous approach indication) to its predicate devices.
- Study Name: Non-clinical Test Summary
- Study Type: Bench Testing, Mechanical Performance Comparison.
- Methodology:
- Tests were conducted according to ASTM F1717-09, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
- Specific tests included: Static Compression Bending, Static Torsion, and Dynamic Compression Bending.
- The "acceptance criteria" here were that the results of these tests for the new device configuration should be "equal or higher" than those of the predicate devices.
- Results: The new device configuration for the APEX Spine System with cannulated pedicle screws met these performance criteria, with results reported as "equal or higher than the predicate systems."
- Conclusion: Based on these non-clinical tests, the manufacturer concluded that the APEX Spine System with the added cannulated pedicle screws is substantially equivalent to the predicate devices in terms of intended use, design, materials, performance, and function. No clinical studies were performed for this submission, as substantial equivalence was demonstrated through non-clinical testing and comparison to legally marketed predicate devices.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.