(78 days)
Not Found
No
The device description and intended use focus on mechanical components for spinal fixation and powered instrumentation for screw insertion. There is no mention of AI or ML in the provided text.
Yes
The device is a spinal system intended for fixation, stabilization, and fusion of the spine to treat various spinal conditions, which are therapeutic actions.
No
Explanation: The provided text describes the XIA® 4.5 Spinal System as an implantable device used for surgical fixation in the spine. Its intended use and indications for use clearly define it as a treatment device for spinal conditions, not a device designed to diagnose them.
No
The device description explicitly details hardware components such as screws, hooks, staples, rods, and connectors, as well as power adaptor instruments. This indicates it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text clearly describes the device as a spinal system intended for surgical implantation to provide fixation and stabilization of the spine for various conditions like degenerative disc disease, spondylolisthesis, trauma, etc. This is a therapeutic and structural function within the body.
- Device Description: The description details components like screws, hooks, rods, and connectors, which are all physical implants used in surgery. It also mentions instruments for inserting these implants.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro (outside the body) for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes.
The XIA® 4.5 Spinal System is an implantable surgical device, not a device used to test samples outside the body.
N/A
Intended Use / 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.
Intended Use (Power Adaptor Instrument Accessory):
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 Adaptor Instrument Accessory):
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, 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.
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.
Product codes
NKB, OSH, MNH, MNI, KWP, KWQ
Device Description
-
The XIA® 4.5 Spinal System is comprised of monoaxial and polyaxial bone and reduction screws, hooks, dual staples, and blockers that affix rods, rod-to-rod connectors, growth connectors, and cross connectors to vertebrae of the spinal column. This submission will introduce new cannulated and non-cannulated polyaxial screws, dual lead self-tapping cortical thread screws, a blocker, top loading rod-to-rod connectors, angled side/top loading connectors, and transition rods. The new XIA® 4.5 components consist of additional polyaxial diameter screws (Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø 6.5, Ø8.5 and Ø9.5) in cannulated and non-cannulated designs in various lengths (20mm – 100mm), a blocker, and a new transition rod. The new components will be used in the same manner as the existing predicate XIA® 4.5 Spinal System.
-
The XIA® 4.5 Spinal System 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® 4.5 Spinal System.
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, 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 Stryker Spine XIA® 4.5 Spinal Systems, with the incorporation of the subject components, has demonstrated substantial equivalence to the predicate device. Engineering analysis and applicable ASTM testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k) May 3, 2004 were completed for the systems. The following mechanical and characterization tests were performed:
- Static Compression (per ASTM F1717-14) Static Torsion (per ASTM F1717-14) Dynamic Compression Bending (ASTM F1717-14) Axial Pull Out Strength (per ASTM F2193-14 / ASTM F543-13) Flexion - Extension (per ASTM F1798-13) Axial Gripping (per ASTM F1798-13) Axial Torque Gripping (per ASTM F1798-13) Axis Tightening Torque
- Power Screw Insertion - Cadaveric Validation Study
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker Spine XIA® 4.5 Spinal System, K142381, K140276, K133188, K121342, K060361, Medtronic CD Legacy (Horizon), K020709, DePuy Motech Moss Miami, K950697, Stryker Spine RADIUS® Spinal System, K101144, Stryker Spine XIA® 3 Spinal System, K142381, Stryker Spine Power Adaptor Instrument Accessory, K120434
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a human face in profile, with three overlapping faces suggesting community and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2015
Stryker Corporation Ms. Sorava King Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K152632 Trade/Device Name: XIA® 4.5 Spinal Fixation System, Power Adaptor Instrument Accessory Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ Dated: September 14, 2015 Received: September 16, 2015
Dear Ms. King:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/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 yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. 0910-0120 | DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|---|
| Expiration Date: January 31, 2017 | Food and Drug Administration |
| See PRA Statement below. | Indications for Use |
| 510(k) Number (if known) | K152632 |
|---|---|
| Device Name | XIA® 4.5 Spinal Fixation System |
| Indications for Use (Describe) |
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.
| 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."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K152632 |
|---|---|
| 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 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; 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; pseudoarthrosis; 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, pseudoarthrosis, and/or failed previous fusion. This system is intended to be used with
| FORM FDA 3881 (8/14) | Page 1 of 2 |
|---|---|
| PSC Publishing Services (301) 443-6740 | EF |
4
antografi and/or allogues. Pediatic person fixation is limited to a posterior sproach
suites to noissilider pur and selection of suites of services from the supersion in and stages on the services tumor; pseudoarthrosis; and failed previous fusion. (sisonol 10/012 (sisolids sisolioss wi) samterior (unds (anglessons 10 emiser is 1) suman is sistemps (sissement in (semient of discount of the since of the night night in instrument in interest and installed series in and service in a personal of any not of the more in the many of the levels in sincerness гоольшог год рэвлэги гэг тэгэгүүд югсэн эрэг элэг тэгээд байгуулаг. Тэмээ багтаан тэгт
Type of Use (Select one or both, as applicable)
2 Presscription Use (Part 21 CFF 801 Subpart D)
Over The-Counter Use (2) OFF 800 Supper C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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5
| XIA® 4.5 Spinal Fixation System | |
|---|---|
| Submitter | Stryker Corporation |
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Soraya King |
| Regulatory Affairs Project Manager | |
| Phone: 201-749-8296 | |
| Email: Soraya.King@stryker.com | |
| Date | November 23, 2015 |
| Trade Name | 1. XIA® 4.5 Spinal Fixation System |
- Power Adaptor Instrument Accessory |
| Proposed Class | Class III |
| Classification Name
and Number | Pedicle Screw Spinal System, 21 CFR 888.3070 |
| Product Code | NKB, OSH, MNH, MNI, KWP, KWQ |
| Predicate Devices | 1. The XIA® 4.5 Spinal Fixation Systems was shown to be
substantially equivalent to the devices listed below:
Primary
Predicate
Stryker Spine XIA® 4.5 Spinal System, K142381 Additional
Predicates Stryker Spine XIA® 4.5 Spinal System (K140276, K133188, K121342, K060361) Medtronic CD Legacy (Horizon), K020709 DePuy Motech Moss Miami, K950697 Stryker Spine RADIUS® Spinal System, K101144 Stryker Spine XIA® 3 Spinal System, K142381 |
| | 2. The Stryker Spine Power Adaptor Instrument Accessory
was shown to be substantially equivalent to the device listed
below:
Additional Predicate Stryker Spine Power Adaptor Instrument Accessory, K120434 |
| Device Description | 1. The XIA® 4.5 Spinal System is comprised of monoaxial and
polyaxial bone and reduction screws, hooks, dual staples, and
blockers that affix rods, rod-to-rod connectors, growth
connectors, and cross connectors to vertebrae of the spinal
column. This submission will introduce new cannulated and |
| XIA® 4.5 Spinal Fixation System | |
| non-cannulated polyaxial screws, dual lead self-tapping
cortical thread screws, a blocker, top loading rod-to-rod
connectors, angled side/top loading connectors, and
transition rods. | |
| The new XIA® 4.5 components consist of additional polyaxial
diameter screws (Ø4.0, Ø4.5, Ø5.0, Ø5.5, Ø 6.5, Ø8.5 and
Ø9.5) in cannulated and non-cannulated designs in various
lengths (20mm – 100mm), a blocker, and a new transition rod.
The newcomponents will be used in the same manner as the
existing predicate XIA® 4.5 Spinal System. | |
| 2. The XIA® 4.5 Spinal System 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® 4.5 Spinal System. | |
| Intended Use and
Indications for Use
for the XIA® 4.5
Spinal System | |
| | 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. |
| XIA® 4.5 Spinal Fixation System | |
| | 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. |
| Indications &
Intended Use with
Power Adaptor
Instrument
Accessory | Intended Use:
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:
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. |
| XIA® 4.5 Spinal Fixation System | |
| 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, 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. | |
| 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 Fixation System | |
| | 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
Technological
Characteristics | 1. The subject XIA® 4.5 Spinal System shares the same
materials, geometries, and fundamental scientific technologies
as the predicate XIA® 4.5 Spinal System. |
| | 2. 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
Non-Clinical Testing
/ Performance Data | The Stryker Spine XIA® 4.5 Spinal Systems, with the
incorporation of the subject components, has demonstrated
substantial equivalence to the predicate device. Engineering
analysis and applicable ASTM testing to demonstrate
compliance with FDA's Guidance for Spinal System 510(k)
May 3, 2004 were completed for the systems. The following
mechanical and characterization tests were performed: |
| | 1.
Static Compression (per ASTM F1717-14) Static Torsion (per ASTM F1717-14) Dynamic Compression Bending (ASTM F1717-14) Axial Pull Out Strength (per ASTM F2193-14 / ASTM F543-13) Flexion - Extension (per ASTM F1798-13) Axial Gripping (per ASTM F1798-13) Axial Torque Gripping (per ASTM F1798-13) Axis Tightening Torque 2.
Power Screw Insertion - Cadaveric Validation Study |
| XIA® 4.5 Spinal Fixation System | |
| Conclusion | Based on the design features, the use of established well-known materials, feature comparisons, indications for use, and results of the mechanical and characterization testing, the subject devices have demonstrated substantial equivalence to the identified predicate devices. |
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