(23 days)
No
The device description focuses on mechanical components and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "spinal fixation" and is intended for various spinal conditions, indicating its use in treating or alleviating a disease or injury.
No
The device description indicates that the Xia® 4.5 Spinal System is comprised of rods, screws, blockers, hooks, staples, and connectors used for spinal fixation. This is a surgical implant system, not a diagnostic tool.
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 a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a spinal implant system consisting of rods, screws, blockers, hooks, staples, and connectors. These are physical devices intended to be surgically implanted into the body to provide structural support and fixation to the spine.
- Intended Use: The intended use clearly states that the system is for "anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation" for various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle 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 Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, KWQ, MNH, and 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.
This submission is intended to address a line extension to Xia ® 4.5 Spinal System. The line extension includes:
- A new size dual staple component in both a rostral and a caudal configuration.
- A new polyaxial cross connector in sizes small, medium, large, and extra large, and
- A new longitudinal rod-to-rod connector to join a Ø 4.5 mm rod from the Xia® 4.5 ■ Spinal System to a Ø 6.0 mm rod from the Xia® Spinal System (K013688, K984251), DIAPASON The Spinal System (K951725), and OPUS "M Spinal System (K993402 & K030369).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal
Indicated Patient Age Range
Not Found
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)
Mechanical testing also demonstrated comparable mechanical properties to the predicate device.
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.
K050461, K052761, K060361, K962628, K950697, K020709
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.
K013688, K984251, K951725, K993402, K030369
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
Special 510(k) Premarket Notification APR 1 3 2006
Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Xia® 4.5 Spinal System
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
Regulatory Affairs Project Manager
Stryker Spine
2 Pearl Court, Allendale, NJ 07401
Tel: (201) 760 - 8145 |
| Date of Summary Preparation: | March 20, 2006 |
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(b)(1) and (b)(2) | |
| Device Product Code: | NKB, KWP, KWQ, MNH, and MNI |
Predicate Device Information:
| | K050461, K052761, K060361 - Stryker Spine Xia®
4.5 Spinal System |
|--|---------------------------------------------------------------------|
| | K962628 - DePuy Spine MOSS Miami™ 4.0
Spinal System |
| | K950697 – Moss Miami 5.0 Spinal System |
| | K020709 - CD Legacy 4.5 Spinal System |
!
.
1
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:
- 트 A new size dual staple component in both a rostral and a caudal configuration.
- 해 A new polyaxial cross connector in sizes small, medium, large, and extra large, and
- A new longitudinal rod-to-rod connector to join a Ø 4.5 mm rod from the Xia" 4.5 ■ Spinal System to a Ø 6.0 mm rod from the Xia® Spinal System (K013688, K984251), DIAPASON The Spinal System (K951725), and OPUS "M Spinal System (K993402 & K030369).
Intended Use:
The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle 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 Stryker Spine DIAPASON"™ Spinal System, Opus™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.
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, K052761, and K060361). Mechanical testing also demonstrated comparable mechanical properties to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2006
Stryker Spine c/o Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, NJ 07401
Re: K060748 Trade/Device Name: Xia® 4.5 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, KWQ, MNH, MNI Dated: March 20, 2006 Received: March 21, 2006
Dear Ms. Voic:
This letter corrects our substantially equivalent letter of April 14, 2006.
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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Ms. Simona Voic
limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours,
Hubert Humphrey
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): $0667 HK
Device Name: Xia 4.5 Spinal System
Indications For Use:
The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle 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, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
elmdel
vision Sign-Off)
Division of General, Restorative. nd Neurological Devices
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