(116 days)
The Stryker Spine TRIO TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin 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); .
- Tumor; .
- Pseudoarthrosis; and .
- Failed previous fusion.
The Trio Trauma Spinal system consists of cannulated pedicle screws in a variety of diameters and lengths, 6.0 mm diameter rods that are offered straight and pre-bent (rad rods) in a variety of lengths and an offset connector. The offset connector is supplied in one size, which accommodates the 6.0 mm diameter rods. The system components are manufactured from Titanium alloy (Ti6Al4V)
The Stryker Spine Trio Trauma Spinal System is a medical device and, as such, its acceptance criteria and the study proving it meets these criteria are based on engineering and mechanical performance tests rather than clinical, AI, or human-reader studies typical for diagnostic devices. Therefore, many of the requested categories (2-9) are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Static Compression Bending Testing | Compared to a predicate system to demonstrate substantial equivalence |
| Dynamic Compression Bending Testing | Compared to a predicate system to demonstrate substantial equivalence |
| Static Torsion Testing | Compared to a predicate system to demonstrate substantial equivalence |
| Static Axial Gripping Capacity Testing | Compared to a predicate system to demonstrate substantial equivalence |
Study Proving Device Meets Acceptance Criteria:
The study involved a series of mechanical performance tests conducted according to ASTM standards.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text. For mechanical testing of medical devices, sample sizes are typically determined by regulatory guidance (e.g., ASTM standards) to ensure statistical significance for material and design performance.
- Data Provenance: The tests (Static Compression Bending, Dynamic Compression Bending, Static Torsion, and Static Axial Gripping Capacity) were performed on the Trio Trauma System components. The location or specific laboratory where these tests were conducted is not mentioned, but the study was part of a regulatory submission to the FDA in the United States. They are considered prospective tests performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The "ground truth" for a mechanical device like a spinal system is defined by its physical properties and mechanical performance under standardized testing conditions, not by expert interpretation. The "experts" involved would be engineers and technicians conducting the tests and interpreting the results against established ASTM standards and predicate device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. Mechanical tests do not involve adjudication in the clinical sense. The results are quantitative measurements interpreted against established standards and predicate device performance.
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:
This is not applicable. This device is a surgical implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
This is not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is the mechanical performance and material properties of the device components as determined by standardized laboratory testing (ASTM F1717 and ASTM F1798). The comparison is made against the established performance of legally marketed predicate devices.
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is not an AI or machine learning study.
9. How the ground truth for the training set was established:
This is not applicable. There is no training set for this type of device submission.
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K103292
Stryker Spine Trio Trauma Spinal System
Traditional 510(k) Premarket Notification
STRYKER SPINE 510(k) Summary: Trio® Trauma Spinal System
MAR - 4 20il
Submitter: Stryker Spine 2 Pearl Court Allendale, New Jersey 07401
Contact Person
Mr. Curtis Truesdale Regulatory Affairs Project Manager Phone: 201-760-8296 FAX: 201-760-8496 Email: curtis.truesdale(@stryker.com
Date Prepared March 4, 2011
Trade Name
Proposed Class Class III
Classification 1) Pedicle Screw Spinal System, 21 CFR §888.3070 Name and Number
Product Code NKB, MNH, MNI
Predicate Devices Synthes Spine USS Fracture System: 510(k) K010658 Stryker Spine Mantis Systems: 510(k) K102235 Stryker Spine Trio+ Spinal System: K100737, K052971 Stryker Spine Xia 4.5 Spinal System: 510(k) K050461, K052761
Stryker Spine Trio® Trauma Spinal System
Device Description The Trio Trauma Spinal system consists of cannulated pedicle screws in a variety of diameters and lengths, 6.0 mm diameter rods that are offered straight and pre-bent (rad rods) in a variety of lengths and an offset connector. The offset connector is supplied in one size, which accommodates the 6.0 mm diameter rods. The system components are manufactured from Titanium alloy (Ti6Al4V)
Page 1 of 2
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Traditional 510(k) Premarket Notification
Intended Use The Stryker Spine Trio Trauma Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segment in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture and dislocation); curvature (i.e. scoliosis, kyphosis, and or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Summary of the Documentation has been provided to demonstrate that the Stryker Technological Spine Trio Trauma Spinal System is substantially equivalent to the Characteristics predicate devices in terms of material, design, mechanical performance and indications for use. Static Compression Bending Testing, Dynamic Compression Bending Testing and Static Torsion Testing per ASTM F1717 were conducted on the Trio Trauma System components. In addition, Static Axial Gripping Capacity testing per ASTM F1798 was also performed. The results obtained from these tests were compared to those of a predicate system to demonstrate substantial equivalence, as recommended by the "Guidance for Industry & FDA Staff Spinal System 510(k)s May 3, 2004."
page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Spine % Mr. Curtis Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
MAR - 4 2011
Re: K103292
Trade/Device Name: Stryker Spine TRIO TRAUMA Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: March 01, 2011 Received: March 02, 2011
Dear Mr. Truesdale:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Mr. Curtis Truesdale
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Aliz B. Rater
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K | 03292
Device Name: Stryker Spine TRIO TRAUMA Spinal System
Indications for Use:
The Stryker Spine TRIO TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin 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); .
- Tumor; .
- Pseudoarthrosis; and .
- Failed previous fusion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
signature
(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Pag 1 of 1
§ 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.