(21 days)
The Xia Spinal System and Xia 4.5 Spinal System are 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.
The 6 mm diameter rods from the DIAPASONTM Spinal System and OPUSTM Spinal System are intended to be used with the other components of the Xia Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.
The Xia® Spinal System contains the same Stainless Steel and Titanium alloy components described in the predicate Xia® Spinal System submission cited above. The Xia® 4.5 Spinal System contains the same Titanium alloy components described in the predicate Xia® 4.5 Spinal System submission cited above. This submission adds an additional indication statement, but no new components.
The provided document is a 510(k) summary for the Stryker Spine Xia® and Xia® 4.5 Spinal Systems. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, performance studies, or clinical trial data as requested in your prompt.
Therefore, I cannot provide the requested information from this document. The document primarily discusses:
- Device Description: The Xia® and Xia® 4.5 Spinal Systems contain Stainless Steel and Titanium alloy components and are adding an additional indication statement.
- Intended Use: Anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for specific spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
- Predicate Devices: Stryker Spine Xia® Spinal System (K053115), Stryker Spine Xia® 4.5 Spinal System (K052761), Medtronic Sofamor Danek's CD Horizon System (K032033).
- Technological Characteristics: Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed.
- FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices.
This type of submission typically relies on non-clinical performance data (e.g., mechanical testing, biocompatibility) to demonstrate equivalence rather than a human-in-the-loop clinical study with experts establishing ground truth, as would be common for AI/diagnostic devices.
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Stryker Spine Xia® and Xia® 4.5 Spinal Systems
510(k) Premarket Notification
2006 140 6
510(k) Summary of Safety and Effectiveness
Xia® Spinal System and Xia® 4.5 Spinal System
| Submitter: | Stryker Spine2 Pearl CourtAllendale, New Jersey 07401 |
|---|---|
| Contact Person | Ms. Simona VoicRegulatory Affairs Project ManagerPhone: 201-760-8145FAX: 201-760-8345Email: simona.voic@stryker.com |
| Date Prepared | February 3, 2006 |
| Trade Name | Xia® Spinal System & Xia® 4.5 Spinal System |
| Proposed Class | Class III |
| Classification Nameand Number | Pedicle Screw Spinal System[21 CFR 888.3070(b) (1) & (b) (2)]Spinal Interlaminal Fixation Orthosis [21 CFR 888.3050]Spinal Intervertebral Body Fixation Orthosis [21 CFR 888.3060] |
| Product Code | NKB, KWP, KWQ MNH, and MNI |
| Predicate Devices | Stryker Spine Xia® Spinal System (K053115)Stryker Spine Xia® 4.5 Spinal System (K052761)Medtronic Sofamor Danek's CD Horizon System (K032033) |
| Device Description | The Xia® Spinal System contains the same Stainless Steel andTitanium alloy components described in the predicate Xia®Spinal System submission cited above. The Xia® 4.5 SpinalSystem contains the same Titanium alloy components describedin the predicate Xia® 4.5 Spinal System submission cited above.This submission adds an additional indication statement, but nonew components. |
| Intended Use | The Xia® Spinal System and Xia® 4.5 Spinal System are intendedfor anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative discdisease (DDD) (defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinalstenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor;pseudoarthrosis; and failed previous fusion.The 6mm diameter rods from the DIAPASONTM Spinal System andOPUSTM Spinal System are intended to be used with the othercomponents of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the othercomponents of the Xia® Titanium Spinal System. |
| Summary of theTechnologicalCharacteristics | Compliance with FDA's Guidance for Spinal System 510(k)'sMay 3, 2004 was completed for the Xia® Spinal System andXia® 4.5 Spinal System. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" and is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
hak 6 2006
Stryker Spine C/O Ms.Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K060361
Trade/Device Name: Xia® Spinal System & Xia® 4.5 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Codes: NKB, MNH, MNI, KWP, KWQ Dated: February 8, 2006 Received: February 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
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Page 2 - Ms. Simona Voic
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. 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-firee number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ellmall
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K (0603(e)
Device Name: Stryker Spine Xia® Spinal System and Xia® 4.5 Spinal System
Indications For Use:
The Xia Spinal System and Xia 4.5 Spinal System are 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.
The 6 mm diameter rods from the DIAPASON™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.
Prescription Use X AND/OR (Part 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)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
elmee
(Division Sign-Of Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number_ Ko 6036
1 द
§ 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.