(88 days)
Not Found
No
The document describes a mechanical spinal fixation system and associated power tools. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to provide additional support during fusion for various spinal conditions, indicating its use in treating and managing medical conditions.
No
The device is an orthopedic spinal system intended for surgical use to provide support during fusion in the treatment of spinal instabilities or deformities, not for diagnosing conditions.
No
The device description clearly states that the Xia® 3 Spinal System is comprised of physical components such as screws, blockers, hooks, rods, and connectors, which are hardware. It also mentions the use of power adaptors and drivers, which are also hardware.
Based on the provided text, the Xia® 3 Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Xia® 3 Spinal System Function: The description clearly states that the Xia® 3 Spinal System is an "orthopedic spinal system comprised a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae of the spinal column for the purposes of stabilization, or corrective action through the application of force." It is a physical implant used in vivo (within the body) during surgery.
- Intended Use: The intended use describes treating various spinal conditions by providing structural support and stabilization. This is a surgical intervention, not a diagnostic test performed on a specimen.
Therefore, the Xia® 3 Spinal System falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) Spondylolisthesis Trauma (i.e. fracture of dislocation) Spinal stenosis Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) Tumor Pseudarthrosis Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Intended Use (Power):
To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of Xia® Spinal Systems (Xia® Stainless Steel, Xia® II, Xia® Anterior, and Xia® Precision), Xia® 3 Spinal System, Xia® 4.5 Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux Spinal System, and the ES2® Spinal System.
Product codes
NKB, KWP, KWQ
Device Description
The Xia® 3 Spinal System is an orthopedic spinal system comprised a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae of the spinal column for the purposes of stabilization, or corrective action through the application of force. The system can be rigidly locked into a range of configurations specific to each patient. The Xia® 3 Serrato Line Extension introduces new dual lead screws, with an enhanced cutting flute (also referred to as serrations), offered in the following configurations: Polyaxial Screws, Medial BA Polyaxial Screws, Reduction Polyaxial Screws, and Cannulated Polyaxial Screws.
The Xia® 3 Spinal System, including the new Serrato bone screws, will continue to be used with the Stryker Spine Power Adaptor Accessory Instrument, Stryker Instruments Hudson Modified Trinkle Reamer, the CD3 Cordless Driver 3 System, and the RemB Universal Driver, to facilitate the insertion of the pedicle screws. The adaptors serve as a mechanical interface between the power drivers and screwdriver instruments. When the adaptor is attached to the Hudson Modified Trinkle Reamer, the RemB Corded driver or the CD3 Cordless Driver 3 provides appropriate power to rotate the screw drivers for the insertion of the pedicle screws. The accessory indications for use were updated to reflect the indications for use of the Xia® 3 Spinal System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine
Indicated Patient Age Range
skeletally mature patients, pediatric 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)
The Xia® 3 Spinal System has demonstrated substantial equivalence to the predicate device. Engineering analysis and applicable ASTM testing completed on the subject system demonstrate compliance with FDA's Guidance for Spinal System 510(k) May 3, 2004. The following mechanical tests were performed:
Static Compression (per ASTM F1717-15)
Static Torsion (per ASTM F1717-15)
Dynamic Compression Bending (ASTM F1717-15)
Axial Gripping Capacity (per ASTM F1798-13)
Axial Torque Gripping Capacity (per ASTM F1798-13)
Flexion - Extension (per ASTM F1798-13)
Axial Pull Out (per ASTM F2193-14 / ASTM F543-13)
On Axis Tightening Torque
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K142381, K152632, K020709, K950697, K101144, K152632
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Corporation Meriam Gabera, MS, RAC Associate Manager, Regulatory Affairs 2 Pearl Court Allendale, New Jersey 07401
May 16, 2017
Re: K170496
Trade/Device Name: Xia® 3 Spinal System - Serrato, Stryker Spine Power Adaptor Instrument Accessory Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: April 19, 2017 Received: April 20, 2017
Dear Ms. Gabera:
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 CFR
Image /page/0/Picture/11 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170496
Device Name Xia® 3 Spinal System - Serrato
Indications for Use (Describe)
The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
· Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e. fracture of dislocation)
- · Spinal stenosis
- · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K170496
Device Name
Stryker Spine Power Adaptor Instrument Accessory
Indications for Use (Describe)
Intended Use (Power):
To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of Xia® Spinal Systems (Xia® Stainless Steel, Xia® II, Xia® Anterior, and Xia® Precision), Xia® 3 Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux Spinal System, and the ES2® Spinal System.
Indications for Use (Power):
The Xia® Spinal System is intended for anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation 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; curvature (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Xia® 3, RADIUS® Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/ anteriolateral and posterior, non-cervical pedicle fixation system, the Xia® II, Xia® 3, and Radius® Spinal Systems are intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Xia® 4.5 Spinal System is intended for anterior/anteral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture of dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudarthrosis; failed previous fusion.
The Stryker Spine Diapson® Spinal System, Opus® Spinal System, and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatic patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Mantis® Spinal System, Mantis® Redux Spinal System, and ES2® Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Type of Use (Select one or both, as applicable)
ك Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
| 510(k) Summary as required by 21CFR§807.92(c): | |
|---|---|
| Xia® 3 Spinal System – Serrato Line Extension | |
| Submitter | Stryker Corporation |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Contact Person | Meriam Gabera, MS, RAC |
| Associate Manager, Regulatory Affairs | |
| Phone: 201-749-8043 | |
| Fax: 201-831-3000 | |
| E-mail: meriam.gabera@stryker.com | |
| Date Prepared | April 19th, 2017 |
| Trade Name | Xia® 3 Spinal System – Serrato |
| Stryker Spine Power Adaptor Accessory | |
| Common Name | Pedicle Screw Spinal System |
| Proposed Class | Class II |
| Classification Name, | |
| Codification | Pedicle Screw Spinal System, 21 CFR § 888.3070 (b)(1) & (b)(2) Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 |
| Product Codes | NKB, KWP, KWQ |
| Predicate Devices | Primary Predicate: Xia® 3 Spinal System - K142381 Additional Predicates: Xia® 4.5 Spinal System - K152632 CD Legacy (Horizon) - K020709 Moss Miami - K950697 Radius® Spinal System - K101144 Stryker Spine Power Adaptor Instrument Accessory - K152632 |
| Device Description | The Xia® 3 Spinal System is an orthopedic spinal system comprised a |
| variety of shapes and sizes of screws, blockers, and hooks that affix | |
| several different types of rods and connectors to vertebrae of the spinal | |
| column for the purposes of stabilization, or corrective action through | |
| the application of force. The system can be rigidly locked into a range of | |
| configurations specific to each patient. The Xia® 3 Serrato Line | |
| Extension introduces new dual lead screws, with an enhanced cutting | |
| flute (also referred to as serrations), offered in the following | |
| configurations: Polyaxial Screws, Medial BA Polyaxial Screws, Reduction | |
| Polyaxial Screws, and Cannulated Polyaxial Screws. | |
| The Xia® 3 Spinal System, including the new Serrato bone screws, will | |
| continue to be used with the Stryker Spine Power Adaptor Accessory | |
| Instrument, Stryker Instruments Hudson Modified Trinkle Reamer, the | |
| CD3 Cordless Driver 3 System, and the RemB Universal Driver, to | |
| facilitate the insertion of the pedicle screws. The adaptors serve as a | |
| mechanical interface between the power drivers and screwdriver | |
| instruments. When the adaptor is attached to the Hudson Modified | |
| Trinkle Reamer, the RemB Corded driver or the CD3 Cordless Driver 3 | |
| provides appropriate power to rotate the screw drivers for the insertion | |
| of the pedicle screws. The accessory indications for use were updated to | |
| reflect the indications for use of the Xia® 3 Spinal System. | |
| Intended use and | The Xia® 3 Spinal System is intended for use in the non-cervical spine. |
| Indications for Use for | When used as an anterior/anterolateral and posterior, non-cervical |
| the Xia® 3 Spinal System | pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is |
| intended to provide additional support during fusion using autograft or | |
| allograft in skeletally mature patients in the treatment of the following | |
| acute and chronic instabilities or deformities: | |
| Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) Spondylolisthesis Trauma (i.e. fracture of dislocation) Spinal stenosis Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) Tumor Pseudarthrosis Failed previous fusion | |
| The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System. |
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. |
| Intended use and
Indications for Use with
the Power Adaptor
Instrument Accessory | Intended Use (Power):
To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of Xia® Spinal Systems (Xia® Stainless Steel, Xia® II, Xia® Anterior, and Xia® Precision), Xia® 3 Spinal System, Xia® 4.5 Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux Spinal System, and the ES2® Spinal System.
Indications for Use (Power): |
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8
9
The Xia® Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation 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; curvature (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Xia® 3, RADIUS® Spinal Systems are intended for use in the noncervical spine. When used as an anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® II, Xia® 3, and Radius® Spinal Systems are intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 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 Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture of dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; failed previous fusion.
The Stryker Spine Diapson® Spinal System, Opus® Spinal System, and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
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When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Mantis® Spinal System, Mantis® Redux Spinal System, and ES2® Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-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 (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.
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| Summary of
Technological
Characteristics | The Xia® 3 Spinal System shares the same materials, fundamental
scientific technologies and similar design as the predicate device. The
Xia® 3 bone screws are also intended to be inserted manually or under
power (cordless and corded) utilizing the CD3 Cordless Driver 3
or the RemB Universal Driver hand held devices. Both drivers connect to
the screwdriver via the Hudson Modified Trinkle Reamer which mates
to the Stryker Spine Power Adaptor. The power adaptor accessory
instrument assembly aids in the rotation of the bone screw to facilitate
insertion. No changes were made to the existing power adaptor
accessory instruments to accommodate the subject device. |
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| Summary of
Performance Data | The Xia® 3 Spinal System has demonstrated substantial equivalence to
the predicate device. Engineering analysis and applicable ASTM testing
completed on the subject system demonstrate compliance with FDA's
Guidance for Spinal System 510(k) May 3, 2004. The following
mechanical tests were performed:
Static Compression (per ASTM F1717-15) Static Torsion (per ASTM F1717-15) Dynamic Compression Bending (ASTM F1717-15) Axial Gripping Capacity (per ASTM F1798-13) Axial Torque Gripping Capacity (per ASTM F1798-13) Flexion - Extension (per ASTM F1798-13) Axial Pull Out (per ASTM F2193-14 / ASTM F543-13) On Axis Tightening Torque |
| Conclusion | Based upon the analysis of the design features, the use of established
well-known materials, feature comparisons, the identical indications for
use, and the results of the mechanical and characterization testing, the
Xia® 3 Spinal System has demonstrated substantial equivalence to the
identified predicate device system. |