(29 days)
The TiLock? Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis: spinal tumor; and failed previous fusion (pseudarthrosis).
The Genesys Spine TiLock2 Spinal System is offered in polyaxial screws (solid and cannulated) and monoaxial screws in various lengths and diameters, offset connectors, washers, hooks, rod-to-rod connectors, lock screws, crosslinks, and rods in various lengths and materials.
This document is a 510(k) premarket notification for a spinal system (TiLock2 Spinal System). The key takeaway is that this submission is for minor modifications to an already cleared device, rather than a completely new device. Therefore, it asserts substantial equivalence to its predicate devices without requiring new performance data for the implants themselves.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Implant Performance | The TiLock2 Spinal System implants must be substantially equivalent in performance and safety to previously cleared predicate devices. This implicitly means that their mechanical strength, biocompatibility, and intended function are maintained. | The TiLock2 Spinal System implants remain unchanged from their previously cleared configuration (K100757, K103034, and K152039). As such, it is stated that "no new testing or analysis is required." The document further asserts that "all of the implants have been previously cleared they do not present any new risks to mechanical strength or performance." The devices are "utilized in the same manner as the predicate devices." |
| Instrument Performance | System instrumentation, even with minor alterations, must function as intended and mimic previously cleared instruments without introducing new safety or effectiveness concerns. | The document states, "The instrument additions mimic previously cleared instruments with minor alterations." It concludes that "the added system instrumentation are all derivatives of previously cleared system devices and do not add any new technology or novel characteristics." Therefore, no new performance data was considered required. |
| Indications for Use | The TiLock2 Spinal System must be indicated for the same uses as its predicate devices, covering immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients for various spinal instabilities and deformities. | The Indications for Use for the TiLock2 Spinal System are identical to the predicate device in content (K152039), and cover immobilization and stabilization of spinal segments as an adjunct to fusion for: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). This demonstrates equivalence in intended use. |
| Material Composition | The implantable components must be manufactured from medical grade materials previously established as safe and effective for spinal implants (e.g., Ti-6Al-4V ELI titanium alloy and cobalt-chromium-molybdenum alloy). | The implantable components are manufactured from "medical grade Ti-6Al-4V ELI titanium alloy per ASTM F136 and cobalt-chromium-molybdenum alloy per ASTM F1537," which aligns with accepted materials for spinal implants and likely matches the predicate devices. |
| Technological Characteristics | The fundamental design and mechanisms of action of the system (e.g., polyaxial/monoaxial screws, rod connectors, etc.) must remain consistent with the predicate. | The "technology and characteristics of the TiLock2 Spinal System remains unchanged." It is composed of the same types of components (polyaxial/monoaxial screws, offset connectors, washers, etc.) as the predicate, and allows for the placement of 5.5mm titanium or cobalt chromium rods. The cannulated polyaxial screws may be implanted via a minimally invasive technique, which is a feature of the predicate. |
| New Risks | The modifications (adding a product code, clarifying classification, minor instrument revisions) must not introduce any new types of safety or effectiveness risks. | The submission specifically states that the implants "do not present any new risks to mechanical strength or performance." The added instrumentation "do not add any new technology or novel characteristics." This is the core argument for not requiring new performance data. |
Study Details:
This submission is a Special 510(k), which means it relies on demonstrating substantial equivalence to previously cleared predicate devices for minor modifications, rather than presenting new comprehensive performance studies for the device itself. The "study" here is essentially the comparison and justification presented in the 510(k) submission.
- No new performance data was required for this submission. The rationale is that the TiLock2 Spinal System implants remain unchanged from their previously cleared configuration (K100757, K103034, and K152039), and the instrument additions mimic previously cleared instruments with only minor alterations. Therefore, no new testing or analysis was deemed necessary.
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 / Not provided. As no new performance testing was conducted for this specific 510(k) submission (K171838), there is no "test set" of data in the traditional sense that would have a sample size or provenance. The determination of substantial equivalence relied on the previous clearance of the implant components and the assertion that new instruments were minor modifications.
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 / Not provided. There was no new "test set" requiring ground truth establishment by experts for this submission. The regulatory body (FDA) reviews the substantial equivalence argument based on engineering principles, material science, and comparison to predicates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No specific test set with an adjudication method was conducted or referenced in this 510(k).
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
- No. This device is a mechanical spinal implant system, not an AI/imaging device. Therefore, MRMC studies and AI assistance are irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a mechanical spinal implant system. This concept is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided directly for this submission. For the original predicate devices, the "ground truth" for their safety and effectiveness would have been established through a combination of:
- Mechanical testing: Demonstrating compliance with relevant ASTM standards for spinal implants (strength, fatigue, etc.).
- Material characterization: Verification of material specifications (ASTM F136, ASTM F1537) and biocompatibility.
- Preclinical studies (if applicable): Though not explicitly mentioned, some predicate devices might have undergone such studies.
- Clinical experience/literature: Supporting the general safety and effectiveness of similar devices and surgical approaches.
- FDA assessment: The FDA's review and clearance of the predicate devices (K100757, K103034, K152039, K122145) established their "ground truth" of substantial equivalence.
8. The sample size for the training set
- Not applicable. This device is a mechanical spinal implant system. The concept of a "training set" is generally used for machine learning or AI models, which is not relevant here.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.