(53 days)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the TSRH®Spinal System is Indicated as an adjunct to fusion for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) disiocation, (5) scollosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudanthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated as an adjunct to fusion for skeletally mature patients using allograft and/or autograft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solld fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (1.e., scollosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylollsthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scollosis, kyphosis and/or lordosis); tumor; pseudarthrosls; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idlopathic scollosis. The TSRH® Pedlatric Spinal System Is Intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates, and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
A subset of TSRH® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, plates, and connecting components as well as CD HORIZON® Spinal System components cleared for pediatric use such as Low Profile MULTI-SPAN® CROSSLINK® Plates, and CD HORIZON® rods, screws, set screws and locking screws. Similarly to the TSRH® implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case. All screws used In pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium alloy and medical grade cobalt -chromiummolybdenum alloy.
TSRH® Spinal System staples, unit rods, s-rods and 7:0 mm diameter rods are specifically excluded for use in pediatric patients.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System in non-pediatric components. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking screws; DYNALOK® PLUS bolts, and VANTAGE™ Anterior Fixation System screws.
The hooks are Intended for posterior use only. The staples are for anterior use only. The TSRH-3D® and TSRH® 3Dx™ connectors, and TSRH-3D® and TSRH® 3Dx™ screws are intended for posterior use only. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH® Spinal System Implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromiummolybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanium, titanium alloy, and/or cobalt-chromiummolybdenum alloy with stainless steel in the same construct.
The acceptance criteria and study proving device efficacy for the TSRH® Spinal System are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Testing |
|---|---|---|
| Material Equivalence | The subject device (TSRH® 3Dx Chromaloy Plus Straight 5.5mm Diameter Rod) should use materials substantially equivalent to legally marketed predicate devices. | The subject device is fabricated from Wrought Cobalt-28Chromium-6Molybdenum, Single Annealed (ASTM F1537), which is identical in material to the predicate TSRH® Spinal System (K103049) and very similar to the CD HORIZON® Spinal System (K093058) which uses a double annealed version of the same material. The difference in annealing was deemed not to introduce new issues of safety or effectiveness. |
| Dimensional Equivalence | The subject device dimensions (length and diameter) should be within acceptable ranges compared to predicate devices. | The subject device is a 5.5mm diameter rod, which is identical in diameter to both predicate devices. The length is 500mm, which is identical to the length of the CD HORIZON® Spinal System predicate (K093058) and within the range for the TSRH® Spinal System predicate (K103049), which has lengths of 30mm-120mm. The specific length of 500mm for the subject device is directly comparable to a predicate. |
| Mechanical Performance | The subject device must demonstrate equivalent mechanical properties (static and fatigue) to predicate devices, ensuring it can withstand physiological loads without failure. This is often assessed by demonstrating compliance with relevant ASTM standards for spinal implants. | Non-clinical mechanical testing was performed:1. ASTM F1798-97 (2008), "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants." Specifically, an axial grip test around the rod was performed.2. ASTM F2193 (2002), "Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System." Specifically, four-point fatigue testing was performed.Medtronic believes that the results of this testing, combined with supporting documentation, demonstrate that the subject device does not introduce new issues of safety, effectiveness, or performance. This implies that the device met the performance requirements/benchmarks established by these ASTM standards, which are considered appropriate for spinal fixation components. The submission states that the device is "substantially equivalent to its predicate devices" based on this testing, indicating that its mechanical performance is comparable and acceptable. |
| Indications for Use | The indications for use of the subject device should be substantially equivalent to those of the predicate devices. | The subject device, the TSRH® 3Dx CHROMALOY™ + Straight 5.5mm Diameter Rod, is stated to be identical to its predicate devices in its indications. The broad indications for the TSRH® Spinal System, including its use as a pedicle screw fixation system in specific conditions (degenerative disc disease, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion, severe spondylolisthesis) and as a non-pedicle screw fixation system, as well as for anterior use and in pediatric patients for adolescent idiopathic scoliosis, are maintained. This identity in indications serves as an acceptance criterion for substantial equivalence. |
| Fundamental Technology | The fundamental scientific technology of the subject device should be consistent with that of the predicate devices, meaning it operates on the same basic principles for spinal fixation. | The fundamental scientific technology (rod and screw system) of the subject device is stated to be identical to both predicate devices (CD HORIZON® Spinal System K093058 and TSRH® Spinal System K103049). This confirms that the mechanical principles of stabilization and fusion it employs are the same as previously cleared devices. |
| Safety and Effectiveness | The subject device must not introduce new issues of safety or effectiveness compared to the predicate devices. This is a general overarching criterion. A risk analysis should be completed. | A risk analysis was completed, and the non-clinical mechanical testing (ASTM F1798-97 and ASTM F2193) was performed. These activities, along with the device's technological characteristics being largely identical or substantially equivalent to the predicates, led Medtronic to conclude that the device does not introduce new issues of safety, effectiveness, or performance. This effectively serves as the performance outcome, showing the acceptance criteria for safety and effectiveness have been met. |
2. Sample Size Used for the Test Set and Data Provenance
No sample size for a test set (clinical or otherwise) is specified in the provided document, as the study described is a non-clinical bench testing study focusing on mechanical properties and material equivalence. There is no human or animal data referenced, thus no data provenance (e.g., country of origin, retrospective/prospective) is applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a non-clinical bench study. Ground truth, in the context of clinical studies, typically refers to a definitive diagnosis or outcome confirmed by expert consensus, pathology, or other objective measures. For mechanical testing, the "ground truth" is defined by the performance standards outlined in the ASTM specifications.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical bench study. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies among expert readers/diagnosticians.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission pertains to a medical device's substantial equivalence based on material and mechanical performance, not a diagnostic or screening algorithm requiring assessment of human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This document describes a physical medical device (spinal rod), not an algorithm or AI system.
7. The Type of Ground Truth Used
For this non-clinical study, the "ground truth" is effectively the established performance specifications and methodologies dictated by recognized industry standards:
- ASTM F1798-97 (2008): "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants."
- ASTM F2193 (2002): "Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System."
Meeting the requirements set forth in these standards, as interpreted and applied by the manufacturer, constitutes the "ground truth" for mechanical equivalence.
8. The Sample Size for the Training Set
Not applicable. This was a non-clinical bench study, not an AI or machine learning study, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
§ 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.