(11 days)
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities. The line extension is for new connectors.
Yes
The device is described as a "Spinal System" intended for "posterior noncervical pedicle fixation" and "anterolateral and posterior, non-cervical, nonpedicle fixation" to provide "additional support during fusion." These uses align with the definition of a therapeutic device designed to treat or alleviate medical conditions.
No
The device is a spinal system (implants like rods, screws, hooks, etc.) used for fixation and support during spinal fusion, not for diagnosing conditions.
No
The device description explicitly states it is comprised of physical components like rods, screws, blockers, hooks, staples, and connectors, fabricated from titanium alloy. This indicates it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical implantation to provide support during spinal fusion. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a system of rods, screws, blockers, hooks, staples, and connectors made of titanium alloy. These are physical implants used in surgery.
- No mention of in vitro testing: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or performing any tests outside of the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The XIA 9 4.5 Spinal System is intended for posterior noncervical pedicle fixation for the following indications: severe spondylolisthesis (i.e. Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), 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 also intended for anterolateral and posterior, non-cervical, nonpedicle fixation 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.
The XIA® 4.5 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients only.
Product codes
87 KWP, 87 KWQ, 87 MNH, 87 MNI
Device Description
The Stryker Spine Xia" 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial bone screws, Blockers, Hooks. Dual Staples, and Connectors. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants are provided non-sterile and are used for either posterior or anterolateral non-cervical spinal fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical pedicle fixation, non-cervical, nonpedicle fixation
Indicated Patient Age Range
skeletally mature patients only
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
Mechanical testing also demonstrated comparable mechanical properties to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
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
Special 510(k) Summary of Safety and Effectiveness:
| Submission Information | |
|---|---|
| Name and Address of the Sponsor | |
| of the 510(k) Submission: | Stryker Spine |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Contact Person: | Simona Voic |
| Sr. Regulatory Affairs Project Manager | |
| Stryker Spine | |
| 2 Pearl Court, Allendale, NJ 07401 | |
| Tel: (908) 522 - 3482 | |
| Date of Summary Preparation: | February 27, 2012 Revised |
| Device Identification | |
| Proprietary Name: | Xia® 4.5 Spinal System |
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis, |
| 21 CFR §888.3050 | |
| Spinal Intervertebral Body Fixation Orthosis | |
| 21 CFR §888.3060 | |
| Pedicle Screw Spinal System | |
| 21 CFR §888.3070 | |
| Device Product Code: | 87 KWP: Appliance, Fixation, Spinal Interlaminal |
| 87 KWQ: Appliance, Fixation, Spinal, | |
| Intervertebral Body | |
| 87 MNH: Spondylolisthesis Spinal Fixation System | |
| 87 MNI: Orthosis, Spinal, Pedicle Fixation | |
| Predicate Device Information: | K050461 - Xia® 4.5 Spinal System |
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K052761 Page 2/2
Predicate Device Identification
The Stryker Spine Xia" 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial bone screws, Blockers, Hooks. Dual Staples, and Connectors. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants are provided non-sterile and are used for either posterior or anterolateral non-cervical spinal fixation.
Description of Device Modification
This submission is intended to address a line extension to Xia" 4.5 Spinal System. The line extension includes a new range of Titanium alloy connectors.
Intended Use:
The XIA 9 4.5 Spinal System is intended for posterior noncervical pedicle fixation for the following indications: severe spondylolisthesis (i.e. Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), 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 also intended for anterolateral and posterior, non-cervical, nonpedicle fixation 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.
The XIA® 4.5 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients only.
Statement of Technological Comparison:
The subject components share the same intended use. material, and basic design concepts as that of the predicate device: Xia" 4.5 Spinal System (K050461). Mechanical testing also demonstrated comparable mechanical properties to the predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Spine % Ms. Simona Voic Senior RA Project Manager 2 Pearl Court Allendale, New Jersey 07401
MAR 1 6 2012
K052761 Re: Trade/Device Name: XIA® 4.5 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNI, MNH, KWP, KWQ Dated: September 29, 2005 Received: September 30, 2005
Dear Ms. Voic:
This letter corrects our substantially equivalent letter of October 11, 2005.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your occurrent the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 to May 28, 1976, the enactment date of the Medical Device Amendnents or to connineres phor to May 20, 1978, are oneonance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The eeneral therefore, marker the devices subject to the genirements for annual registration, listing of devices, controls provisions of the rice not not and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class II (PMA), it If your device is classified (300 a0010). Existing major regulations affecting your device can be may be subject to additions, 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 Please be advised that FDA s issuation of a buccession as of the other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decemination and regulations administered by other Federal agencies and light of any Federal statutes and regulations adminities, but not limited to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to: r comply with an the Act 3 requirences and 801); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set do rico-relation activers of child) (2) CFR Part 820); and if applicable, the electronic forth in the quality by evense (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 IT you desire specific advice to: your as ritersOffices/CDRHOffices/ucm115809.htm for go to mp.77WWW.Gallern in Radiological Health's (CDRH's) Office of Compliance. Also, please the Comer for Devices and Nassessor ing by reference to premarket notification" (21CFR Pat 1 note the regulations 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 Tou may obtain only general manufacturers, International and Consumer Assistance 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 A. Millburn
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Xia 4.5 Spinal System
Indications For Use:
The XIA* 4.5 Spinal System is intended for posterior noncervical pedicle fixation for the following indications: severe spondylolisthesis (i.e. Grades 3 and 4 at L5-S1 or degeneralive spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e. fracture of Spondylolishis with blyoches (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
The XIA 4.5 Spinal System is also intended for anterolateral and posterior, non-cervical, nonpedicle fixation 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), discogenic ongin with degonoration of tracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, sponationstholo, transa (trenor, pseudoarthrosis and failed previous fusion.
The XIA® 4.5 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients only.
AND/OR Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K052761 510(k) Number_