(29 days)
Not Found
No
The document describes a spinal fixation system and associated instrumentation for screw insertion. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The focus is on the mechanical components and their intended use in surgical procedures.
Yes
The device is a spinal system intended to treat various spinal conditions, including degenerative disc disease, trauma, and deformities, to provide support during fusion. Its primary function is to address medical conditions and restore function, aligning with the definition of a therapeutic device.
No
This device is a spinal system intended for surgical implantation to provide fixation and support for the spine. It is not designed to diagnose medical conditions but rather to treat them.
No
The device description clearly outlines various hardware components like bone screws, hooks, staples, rods, and connectors, which are physical implants used in spinal surgery. The document also mentions power adaptors and drivers, which are also hardware. There is no mention of software as the primary or sole component of this medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Description and Intended Use: The description clearly states that the XIA® 4.5 Spinal System is comprised of implants (screws, hooks, rods, etc.) and instruments used for surgical fixation of the spine. Its intended use is to treat various spinal conditions by providing structural support and facilitating fusion.
- No Mention of Specimen Analysis: The text does not mention any analysis of biological specimens or providing diagnostic information based on such analysis.
Therefore, the XIA® 4.5 Spinal System is a surgical implant and instrumentation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The XIA® 4.5 Spinal System is intended for anteriolateral 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 DIAPASON® 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.
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.
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 implanted in the non-cervical spine usine 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® 4.5 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 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 non-cervical 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); tumor; pseudoarthrosis; and failed previous fusion.
The XIA® 4.5 Spinal System is intended for 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, and/or lordosis); tumor; pseudarthrosis; failed previous fusion.
The Stryker Spine DIAPASON® 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, kyphosis, including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolysis, fracture caused by tunor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allografi. 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, 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 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 dise 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.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, KWQ
Device Description
The XIA® 4.5 Spinal System is comprised of Monoaxial, Polyaxial and reduction bone screws, Cortical Trajectory (CT) bone screws (cannulated and non-cannulated), hooks, dual staples, and blockers that affix rods, rod-to-rod connectors, growth connectors, and cross connectors to vertebrae of the spinal column.
The subject submission will introduce line extension of non-cannulated dual lead self-tapping Xia® Cortical trajectory (CT) bone screws, sub components of existing XIA® 4.5 Spinal System. Ø5.5, Ø 6.5, and Ø7.5 with a length of 35mm-70mm screws are to be added. The new components will be used in the same manner as the predicate XIA® 4.5 Spinal System.
The Xia® 4.5 Spinal System, including the new Xia® Cortical Trajectory implants, will continue to be used with the Stryker Spine Power Adaptor Accessory Instrument. The Stryker Instruments Hudson Modified Trinkle Reamer, the CD3 Cordless Driver 3 System, and the RemB Universal Driver, are used with Stryker Spine Power Adaptor 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical pedicle and non-pedicle fixation for the spinal column.
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)
Engineering analysis demonstrated that XIA® Cortical trajectory (CT) line extension implants does not adversely affect performance of the Xia® 4.5 Spinal System and does not represent a new, worst case scenario. No additional performance data was provided.
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.
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
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October 10, 2017
Stryker Corporation Ms. Priyanka Patel Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K172724
Trade/Device Name: XIA® 4.5 Spinal System, 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: September 8, 2017 Received: September 11, 2017
Dear Ms. Patel:
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 Part 807); labeling (21 CFR Part 801); medical device 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.
1
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
Ronald P. Jean -S for
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)
K172724
Device Name XIA® 4.5 Spinal System
Indications for Use (Describe)
The XIA® 4.5 Spinal System is intended for anteriolateral 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 DIAPASON® 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.
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
Indications for Use
510(k) Number (if known) K172724
Device Name
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 implanted in the non-cervical spine usine 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® 4.5 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 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 non-cervical 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); tumor; pseudoarthrosis; and failed previous fusion.
The XIA® 4.5 Spinal System is intended for 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, and/or lordosis); tumor; pseudarthrosis; failed previous fusion.
The Stryker Spine DIAPASON® 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, kyphosis, including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolysis, fracture caused by tunor and/or
4
trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allografi. 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, 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 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 dise 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
5
| XIA 4.5 Spinal System | |
|---|---|
| Submitter: | Stryker Corporation |
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Priyanka Patel |
| Regulatory Affairs Specialist | |
| Phone: 201-749-8387 | |
| Email: Priyanka.patel@stryker.com | |
| Date Prepared | September 8, 2017 |
| Trade Name | XIA® 4.5 Spinal System, |
| Power Adaptor Instrument Accessory | |
| Proposed Class | Class II |
| Classification Name | |
| and Number | • Thoracolumbosacral Pedicle Screw System, 21 CFR § |
| § 888.3070 | |
| • Spinal Intervertebral Body Fixation Orthosis, 21 CFR § | |
| 888.3060 | |
| • Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 | |
| Product Code | NKB, KWP, KWQ |
| Predicate Devices | The XIA 4.5 Spinal Fixation System was shown to be |
| substantially equivalent to the device listed below: | |
| Primary Predicate | |
| • Stryker Spine XIA® 4.5 Spinal System (K152632) | |
| Device Description | The XIA® 4.5 Spinal System is comprised of Monoaxial, |
| Polyaxial and reduction bone screws, Cortical Trajectory | |
| (CT) bone screws (cannulated and non-cannulated), hooks, | |
| dual staples, and blockers that affix rods, rod-to-rod | |
| connectors, growth connectors, and cross connectors to | |
| vertebrae of the spinal column. |
The subject submission will introduce line extension of non-
cannulated dual lead self-tapping Xia® Cortical trajectory
(CT) bone screws, sub components of existing XIA® 4.5
Spinal System. Ø5.5, Ø 6.5, and Ø7.5 with a length of 35mm-
70mm screws are to be added. The new components will be
used in the same manner as the predicate XIA® 4.5 Spinal
System.
The Xia® 4.5 Spinal System, including the new Xia® Cortical
Trajectory implants, will continue to be used with the
Stryker Spine Power Adaptor Accessory Instrument. The
Stryker Instruments Hudson Modified Trinkle Reamer, the
CD3 Cordless Driver 3 System, and the RemB Universal |
| XIA 4.5 Spinal System | |
| | Driver, are used with Stryker Spine Power Adaptor 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 |
| Intended Use and
Indications for Use | The XIA® 4.5 Spinal System is intended for
anterior/anteriolateral 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 DIAPASON® 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. |
| | 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. |
| XIA 4.5 Spinal System | |
| Indications &
Intended Use with
Powered
Instruments | 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):
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 non-cervical 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; curvature (i.e. scoliosis, |
| Section 8 - 510(k) Summary | |
| XIA 4.5 Spinal System | |
| 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 DIAPASON® 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, 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 | |
6
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Section 8 - 510(k) Summary XIA 4.5 Spinal System 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. Summary of the The Xia® 4.5 Spinal System shares the same materials, Technological fundamental scientific technologies and similar design as Characteristics the predicate device. The Xia® 4.5 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. Summary of The Stryker Spine XIA® 4.5 Spinal Systems, with the Non-Clinical Testing incorporation of the subject components, has demonstrated / Performance Data substantial equivalence to the predicate device. Engineering analysis demonstrated that XIA® Cortical trajectory (CT) line extension implants does not adversely affect performance of the Xia® 4.5 Spinal System and does not represent a new, worst case scenario. No additional performance data was provided. Based on the design features, the use of established well-
known materials, feature comparisons, indications for use
the subject devices have demonstrated substantial equivalence to the identified predicate devices.
Conclusion