(28 days)
No
The 510(k) summary describes a spinal fixation system and focuses on material changes and mechanical testing, with no mention of AI or ML capabilities.
Yes
The device is a spinal fixation system indicated for various conditions like degenerative disc disease, spondylolisthesis, and trauma, aiming to treat or alleviate these medical conditions.
No
The device description clearly states its purpose is for "fixation" in "spinal system," indicating it is an implantable surgical device, not a diagnostic one.
No
The device description clearly states it is a "Stainless Steel Spinal System" and introduces a new material grade for screws, indicating it is a physical hardware device used for spinal fixation.
Based on the provided text, the Xia Stainless Steel Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fixation to treat various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on the material and function of spinal screws, which are used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. The Xia Stainless Steel Spinal System is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Xia Stainless Steel Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Product codes
NKB, MNH, MNI, KWP, KWQ
Device Description
This 510(k) is intended to introduce a new Stainless Steel material grade for the previously cleared Xia long arm Monoaxial and Polyaxial screws (K061854). The Xia® Stainless Steel Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical pedicle and non-pedicle
Indicated Patient Age Range
Not Found
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 and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spine Xia® Stainless Steel modified long arm screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K061854, K012870, K031090, K951725
Reference Device(s)
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.
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K063428
Special 510(k) Premarket Notification
| Special 510(k): Device Modification
Summary of Safety and Effectiveness for
Xia® Stainless Steel Long Arm Screws | DEC 1 1 2006 | |
---|---|---|
Proprietary Name: | Xia® Stainless Steel Spinal System | |
Common Name: | Spinal Fixation Appliances | |
Proposed Regulatory Class: | Class III | |
Spinal Interlaminal Fixation Orthosis, | ||
21 CFR 888.3050 | ||
Spinal Intervertebral Body Fixation Orthosis, | ||
21 CFR 888.3060 | ||
Pedicle Screw Spinal System | ||
21 CFR 888.3070(b)(1) and (b)(2) | ||
Device Product Code: | NKB, MNH, MNI, KWP, KWQ | |
For Information contact: | Simona Voic | |
Regulatory Affairs Project Manager | ||
2 Pearl Court | ||
Allendale, NJ 07401 | ||
Telephone: (201) 760-8145 | ||
Fax: (201) 760-8345 | ||
Email: Simona.Voic@stryker.com | ||
Date Summary Prepared: | November 9, 2006 | |
Predicate Devices | Stryker Spine: | |
• Xia® Spinal System: K061854, K012870, K031090 | ||
• Osteonics Spinal System, K951725 |
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1
K063428
Special 510(k) Premarket Notification
Description of Device Modification This 510(k) is intended to introduce a new Stainless Steel material grade for the previously cleared Xia long arm Monoaxial and Polyaxial screws (K061854). The Xia® Stainless Steel Spinal System is intended for Intended Use anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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. Summary of the Technological Documentation is provided which demonstrates the Characteristics new long arm screws of the Stryker Spine Xia Stainless Steel Spinal System to be substantially equivalent to its predicate devices in terms of its material, design, and indications for use. Engineering
analysis and testing to demonstrate compliance with
FDA's Guidance for Spinal System 510(k)'s May 3,
2004 was completed for the Stryker Spine Xia®
Stainless Steel modified long arm screws.
2
Special 510(k) Premarket Notification
Class III Summary
A Class III Summary has been submitted in predicate 510(k) #K060361 for the entire Stryker Xia Spinal System line, including the Xia Stainless Steel Spinal System. The Class III summary submitted in 510(k) #K060361 also applied to the Xia® long arm titanium alloy and stainless steel screws and hooks cleared via K061854. The Class III summary, incorporated into the current Special 510(k) by reference, reviewed information relevant to the types of safety and effectiveness problems reported for pedicle screw/rod systems when used for the Class III indications 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).
The conclusion of the Class III Summary was that current literature and MAUDE experience reports suggest that the types of safety and effectiveness problems associated with pedicle screw and rod systems are well known and include: device-related events such as screw breakage, component disassembly, pedicle fracture, component migration/loosening/fracture, and infection; and procedure-related events such as intraoperative assembly difficulty, and events associated with any major surgical procedure (such as myocardial infarction, deep vein thrombosis, and urinary tract infection). Complications can lead to revision surgery, and are sometimes associated with neural injury. Further, surgery does not always achieve its goals of stability and pain relief, and patients can develop instability or pain at adjacent spinal segments. The information presented in this summary does not suggest that the Class III use of pedicle screw/rod systems as described in 21 CFR 888.3070 is associated with any different types of safety and effectiveness problems than are seen with the Class II uses of the same pedicle screw/rod systems.
The device modification of the previously cleared Xia® Stainless Steel long arm screws (K061854), to change from one grade of implantable Stainless Steel to another, raises no new types of safety or effectiveness problems, as the devices have been demonstrated through a comparison of design features, materials, intended use, and performance characteristics, to be substantially equivalent to existing Xia® Stainless Steel Spinal System screw and hook components.
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3
CLASS III CERTIFICATION
Certification of Adverse Safety and Effectiveness Information Pursuant to 513(f) of the Federal Food, Drug and Cosmetic Act
I certify that, in my capacity as Senior Director of Regulatory and Clinical Affairs of Stryker Spine I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety and effectiveness problems that have been reported for pedicle screws. I further certify that I am aware of the types of problems to which pedicle screws are susceptible and that, to the best of my knowledge, the summary of the types and causes of safety and/or effectiveness problems about pedicle screws reported in K060361 are complete and accurate.
Susan Kearney
Susan Krasny, RAC, Ph.D. Senior Director, Regulatory and Clinical Affairs
Date: 2 Nov 2006
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Spine % Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
DEC 1 1 2006
Re: K063428
Trade/Device Name: Xia Stainless Steel Spinal System
Regulation Number: 21 CFR 888.3070
Regulation Name: Pedicle screw spinal system
Regulatory Class: Class III
Product Code: NKB, KWP, KWQ, MNI, MNH
Dated: November 9, 2006
Received: November 13, 2006
Dear Ms. Voic:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.
5
Page 2 - Ms. Simona Voic
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buching
Mark N. Melkerson Director Division of General, Restorative, and Neurologic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KOb 3428
Device Name: Xia® Stainless Steel Spinal System
Indications for Use:
The Xia Stainless Steel Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buckner for MCM (Page 1 of 1)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_K06 3428