(118 days)
When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:
- Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Spinal Stenosis .
- Trauma/Fracture/Dislocation .
- Atlanto-Axial Fracture with Instability .
- Occipito-Cervical Dislocation .
- Failed Previous Fusion .
- Tumor .
The use of occipital bone screws is limited to placement in the occiput only.
The use of polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The purpose of this Special 510(k) is to add a modified screw configuration in multiple sizes. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.
The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.
The Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy and/or cobalt chrome alloy per ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.
This document describes the Lanx Posterior Cervicothoracic Spinal Fixation System, which is a spinal fixation system that provides supplemental stabilization of spinal segments to support fusion. This submission is a Special 510(k) to add a modified screw configuration in multiple sizes. The device is substantially equivalent to a predicate device and is intended for use in the occipito-cervico-thoracic region of the spine in skeletally mature patients for various conditions.
Here's the information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (based on predicate device) | Reported Device Performance |
|---|---|---|
| Static Axial Compression | Functioned as intended and demonstrated substantial equivalence to the predicate device. | Functioned as intended and demonstrated substantial equivalence to the predicate device. |
| Dynamic Axial Compression | Functioned as intended and demonstrated substantial equivalence to the predicate device. | Functioned as intended and demonstrated substantial equivalence to the predicate device. |
| Static Torsion | Functioned as intended and demonstrated substantial equivalence to the predicate device. | Functioned as intended and demonstrated substantial equivalence to the predicate device. |
| Static Flexion-Extension | Functioned as intended and demonstrated substantial equivalence to the predicate device. | Functioned as intended and demonstrated substantial equivalence to the predicate device. |
Note: The document explicitly states "functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device." This implies that the acceptance criteria for the modified device were to perform comparably to the previously-cleared predicate device in the specified mechanical tests. The specific quantitative thresholds for "substantial equivalence" or "functioned as intended" are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Performance testing was conducted to characterize the modified components of the system. Tests were performed on the modified and predicate systems..." This implies a comparative test, but the number of units tested is not specified.
- Data Provenance: Not applicable in the context of device performance testing. The tests are experimental/laboratory-based, not based on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is mechanical performance testing of a physical device, not an AI/software device that requires expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is mechanical performance testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the mechanical performance testing of a spinal fixation system, not a study involving human readers or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This document is about a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the mechanical performance testing, the "ground truth" is established by the standardized test methods outlined in ASTM F1717 and ASTM F1798. The performance of the predicate device serves as the benchmark against which the modified device's performance is compared to establish substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device, not a machine learning model.
§ 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.