(28 days)
Not Found
No
The summary describes a line extension of a spinal fixation system, focusing on additional screw lengths. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies are engineering analyses, not clinical studies evaluating AI/ML performance.
Yes
The device is used to immobilize and stabilize spinal segments as an adjunct to fusion for various medical indications such as degenerative disc disease, spondylolisthesis, and trauma, clearly indicating a direct role in treating or managing health conditions.
No
The device is a spinal fixation system, intended for the "immobilization and stabilization of spinal segments" as an "adjunct to fusion." This describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly states it is a "Spinal Fixation System" and a "line extension" consisting of "additional lengths for the 4.5 mm diameter and 5.5 mm diameter standard post screws." This indicates a physical, implantable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion". This describes a surgical implant used in the body, not a device used to examine specimens outside the body.
- Device Description: The description details "additional lengths for the 4.5 mm diameter and 5.5 mm diameter standard post screws". This further confirms it's a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (in a lab setting), or providing diagnostic information based on such analysis.
Therefore, the Stryker Spine TRIO+ Spinal Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Spine TRIO+ Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation 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);
- 트 Spondylolisthesis;
- l Trauma (i.e., fracture or dislocation);
- I Spinal stenosis;
- 트 Curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- . Tumor:
- 트 Pseudoarthrosis; and
- l Failed previous fusion.
The Stryker Spine TRIO+ Spinal Fixation System is intended to be used in conjunction with the OSS/DIAPASON or Opus Rods, Xia pre-bent rods and the Multi-Axis Cross Connector.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI
Device Description
This 510(k) is intended to introduce a line extension to the existing TRIO+ Spinal System. The line extension consists of additional lengths for the 4.5 mm diameter and 5.5 mm diameter standard post screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical pedicle and non-pedicle of the spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis was completed for the subject screw components and demonstrates equivalence to the predicate product as well as compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K052971, K062698, K070368, K020699, K021170
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
TRIO+ Spinal Fixation System -- Line Extension
.
.
Special 510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness: TRIO+ Spinal System - Line Extension
| Proprietary Name: | TRIO+ Spinal Fixation System | APR 12 2010 |
|---|---|---|
| Common Name: | Spinal Fixation Appliances | |
| Classification Name and Reference: | 1) Pedicle Screw Spinal System, 21 CFR §888.3070 (b) (1) & (b) (2) |
- Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060 | |
| Device Product Code: | NKB, MNH, MNI | |
| Proposed Regulatory Class: | Class III | |
| For Information contact: | Curtis Truesdale
Regulatory Affairs Project Manager
2 Pearl Court
Allendale, NJ 07401
Telephone: (201) 760-8296
Fax: (201) 760-8496
Email: Curtis.Truesdale@Stryker.com | |
| Date Summary Prepared: | April 9, 2010 | |
| Predicate Devices | Stryker Spine TRIO Spinal Fixation System, K052971;Stryker Spine TRIO and TRIO+ Spinal Systems,
K062698, K070368.Medtronic Sofamor Danek TSRH Spinal System,
K020699, K021170. | |
1
TRIO+ Spinal Fixation System - Line Extension
Special 510(k) Premarket Notification
Description of Device Modification
Intended Use
This 510(k) is intended to introduce a line extension to the existing TRIO+ Spinal System. The line extension consists of additional lengths for the 4.5 mm diameter and 5.5 mm diameter standard post screws.
The TRIO+ Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation 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);
- 트 Spondylolisthesis;
- l Trauma (i.e., fracture or dislocation);
- I Spinal stenosis;
- 트 Curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- . Tumor:
- 트 Pseudoarthrosis; and
- l Failed previous fusion.
The Stryker Spine TRIO+ Spinal Fixation System is intended to be used in conjunction with the OSS/DIAPASON or Opus Rods, Xia pre-bent rods and the Multi-Axis Cross Connector.
The Stryker Spine TRIO+ Spinal Fixation System, with the Summary of the Technological incorporation of the subject components, is substantially equivalent Characteristics to the predicate devices in terms of material, design, and indications for use. Engineering analysis was completed for the subject screw components and demonstrates equivalence to the predicate product as well as compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Stryker Spine % Mr. Curtis D. Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
APR 1 2 2010
Re: K100737
Trade/Device Name: TRIO® Plus Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: March 01, 2010 Received: March 15, 2010
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 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
3
Page 2 - Mr. Curtis D. Truesdale
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 (OS) 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 vours.
Barbara Buching
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: TRIO+ Spinal Fixation System Line Extension - Additional Screws
Indications for Use:
The Stryker Spine TRIO+ Spinal Fixation System is intended for posterior, noncervical pedicle and nonpedicle 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 (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);
- 트 Tumor:
- 트 Pseudoarthrosis; and
- 트 Failed previous fusion.
The TRIO+ Spinal Fixation System is intended to be used in conjunction with the OSS/DIAPASON or Opus Rods, Xia pre-bent rods and the Multi-Axia Cross Connector.
Prescription Use AND/OR (21 CFR 801 Subpart D)
Over-The-Counter Use (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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K100737 510(k) Number_