(105 days)
Not Found
No
The device description and intended use clearly define the device as a mechanical spinal implant system (screws, plates, and locking components). There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on substantial equivalence to predicate mechanical devices and compliance with spinal system guidance, not algorithmic performance.
No
The device provides immobilization and stabilization of spinal segments, acting as an adjunct to fusion for treating various spinal conditions. It is a surgical implant designed to support the spine, not to perform a therapeutic function itself.
No
The device description indicates it is comprised of spinal screws, plates, and locking components, which are used for immobilization and stabilization of spinal segments. These are therapeutic components inserted into the body, not tools for diagnosis.
No
The device description explicitly states that the Stryker Spine TRIO® PS is comprised of physical components: spinal screws, plates, and locking components, fabricated from titanium alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Stryker Spine TRIO® PS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Stryker Spine TRIO® PS is a surgical implant (spinal screws, plates, and locking components) intended for the immobilization and stabilization of spinal segments. It is physically implanted into the patient's body.
The description clearly indicates a device used in vivo (within the living body) for structural support and stabilization, not for analyzing biological samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The Stryker Spine TRIO® PS is a posterior, noncervical (T10-S1), pedicle system 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 spine: severe spondylolisthesis (grades 3 and 4) at LS-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) turnor, pseudoarthrosis, and previous failed fusion.
The Stryker Spine TRIO® PS is also a sacral screw fixation system indicated for 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, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and previous failed fusion.
Product codes
MNH, MNI
Device Description
The Stryker Spine TRIO® PS is comprised of spinal screws, plates and locking components. The components are available in a variety of sizes in order to accommodate patient anatomy and are fabricated from titanium alloy. The components of the TRIO® PS System will be provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical (T10-S1) spinal segments; LS-S1; sacral
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Testing to demonstrate compliance with FDA's Guidance "Spinal System 510(k)s'', May 3, 2004 was completed for the Stryker Spine TRIO® PS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
| Proprietary Name: | Stryker Spine TRIO® PS |
|---|---|
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Pedicle Screw Spinal System, 21 CFR 888.3070 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 MNH: Orthosis, Spondyloisthesis Spinal Fixation |
| 87 MNI: Orthosis, Spinal, Pedicle Fixation | |
| For Information contact: | Simona Voic |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Telephone: (201) 760-8145 | |
| Fax: (201) 760-8345 | |
| Email: Simona.Voic@stryker.com | |
| Date Summary Prepared: | January 12, 2005 |
510(k) Summary of Safety and Effectiveness: Stryker Spine TRIO® PS
Device Description
The Stryker Spine TRIO® PS is comprised of spinal screws, plates and locking components. The components are available in a variety of sizes in order to accommodate patient anatomy and are fabricated from titanium alloy. The components of the TRIO® PS System will be provided non-sterile.
Predicate Devices:
Xia Spinal System, Howmedica Osteonics Corporation [K013823] Osteonics Spinal System, Osteonics Corporation [K951725]
Intended Use
The Stryker Spine TRIO® PS is a posterior, noncervical (T10-S1), pedicle system 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 spine: severe spondylolisthesis (grades 3 and 4) at LS-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) turnor, pseudoarthrosis, and previous failed fusion.
1
The Stryker Spine TRIO® PS is also a sacral screw fixation system indicated for 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, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and previous failed fusion.
Summary of the Technological Characteristics:
Documentation was provided which demonstrates the Stryker Spine TRIO® PS to be substantially equivalent to its predicate devices in terms of its material, design, and indications for use. Testing to demonstrate compliance with FDA's Guidance "Spinal System 510(k)s'', May 3, 2004 was completed for the Stryker Spine TRIO® PS.
2
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the department's mission of promoting health and well-being.
Public Health Service
MAR 2 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Simona Voic Regulatory Affairs Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401
Re: K043180
Trade/Device Name: Stryker Spine TRIO® Plate System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNH and MNI Dated: January 14, 2005 Received: January 18, 2005
Dear Ms. Voic:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn of 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 10 commerce phat to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have occh recuire approval of a premarket approval application (PMA). and Cosmetic Act (Tel) that do not requent to the general controls provisions of the Act. The 1 ou may, therefore, market and not include requirements for annual registration, listing of general controls provider ing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a007 b) as . Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oouveements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease to advised that I Dr b xetian that your device complies with other requirements of the Act that I DA has Intact a and regulations administered by other Federal agencies. You must or any I edelar statuates and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as se CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Voic
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maning of substantial equivalence of your device to a legally premarket notification: "The I DTT maning of bassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your as at (240) 276-0120 . Also, please note the regulation entitled, Colliact the Office of Comphance and motification" (21CFR Part 807.97). You may obtain other Misolanding of reference to promaibilities under the Act from the Division of Small general information on your responsiblement Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octise. http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K043180
Device Name: Stryker Spine TRIO® PS
Indications For Use:
The Stryker Spine TRIO® PS is a posterior, noncervical (T10-S1), pedicle system 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 As an adjariet to fusion in the «Saine: severe spondylolisthesis (grades 3 and 4) at Instablines of deforming spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or impairmont, tradina (ires), and/or lordosis) tumor, pseudoarthrosis, and previous failed fusion.
The Stryker Spine TRIO® PS is also a sacral screw fixation system indicated for The Ollyker Opine TVTO (Grand as back pain of discogenic origin with degeneration dogonorative dies alosal tistory and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, (f.or, natuary lordosis), tumor, pseudoarthrosis and previous failed fusion.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
Mark N. Milleson
estor dive. and Neurological Devices
Page 1 of 1
510(k) Number K043180