(29 days)
Not Found
No
The document describes a spinal fixation system composed of mechanical components and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for use in patients with severe spondylolisthesis, spinal instabilities, deformities, fractures, tumors, and failed previous fusions, all of which are medical conditions being treated or managed by this device.
No
The provided text describes the Xia® Spinal System as a fixation device used in spinal fusion and stabilization procedures. It outlines its components and indications for use in treating various spinal conditions. There is no mention of the device being used for diagnosis or detection of diseases.
No
The device description explicitly lists physical components such as screws, washers, hooks, rods, and connectors, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Xia® Spinal System is a system of implants (screws, rods, hooks, etc.) intended for surgical implantation in the spine to provide stabilization and support. This is a physical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic testing, or any of the typical components or processes associated with IVDs.
Therefore, the Xia® Spinal System is a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Xia® Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia® Spinal System is intended for patients: (a) having severe spondylolistolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system, the Xia® Spinal System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia® Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
The 6mm diameter rods from the DIAPASON™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, KWQ, KWP
Device Description
This submission is intended to address a line extension to Xia® Spinal System. The line extension includes the addition of Titanium alloy and Stainless Steel 4.0 mm diameter spinal screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
noncervical spine, fifth lumbar - first sacral (L5-S1) vertebral joint, lumbar and sacral spine, thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature 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)
Mechanical testing also demonstrated comparable mechanical properties to the predicate device: Stryker Spine Xia® Spinal System (K013823) and DePuy Inc. Moss Miami Spinal System (K962628).
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.
K012870, K031090, K013823, K962628
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
DEC 6 2005
Special 510(k) Premarket Notification
KDS3115
Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Xia® 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
(201) 760 - 8145 |
| Date of Summary Preparation: | October 31, 2005 |
| Device Identification | |
| Proprietary Name: | Xia® 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 |
| Predicate Device Information: | |
| | Stryker Spine Xia® Stainless Steel System
(K012870 & K031090) |
| | Stryker Spine Xia® Spinal System (K013823) |
| | DePuy Inc., Moss Miami Spinal System (K962628) |
Predicate Device Identification
The Stryker Spine Xia " Spinal Fixation System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, and Connectors. The components are manufactured from either Titanium material (Ti alloy and CP Titanium) or Stainless Steel.
1
Description of Device Modification
This submission is intended to address a line extension to Xia® Spinal System. The line extension includes the addition of Titanium alloy and Stainless Steel 4.0 mm diameter spinal screws.
Intended Use:
The Xia® Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia® Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system, the Xia® Spinal System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia® Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
The 6mm diameter rods from the DIAPASON™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.
2
Statement of Technological Comparison:
The subject components share the same intended use, material, and basic design concepts as that of the predicate device: Stryker Spine Xia® Spinal System (K013823, K012870, and K031090). Mechanical testing also demonstrated comparable mechanical properties to the predicate device: Stryker Spine Xia® Spinal System (K013823) and DePuy Inc. Moss Miami Spinal System (K962628).
3
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services. The seal features the department's logo, which is a stylized caduceus with three lines representing the three branches of government. The logo is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular pattern. The text is written in all capital letters.
Public Health Service
2005 DEC 6
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Simona Voic Regulatory Affairs Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401
Re: K053115
Trade/Device Name: Xia® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWQ, KWP Dated: November 4, 2005 Received: November 7, 2005
Dear Ms. Voic:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 complics 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); 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.
4
Page 2 - Simona Voic
This letter will allow you to begin 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
1 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KOS3115
Indications for Use
510(k) Number (if known): K كا // 510(k) كا
Device Name: Xia® Spinal System
Indications For Use:
ど
The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine: and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system, the Xia Spinal System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Spinal System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
The 6mm diameter rods from the DIAPASON™ Spinal System and OPUS" Spinal System are intended
to be used with the other components of the Xia " Titanium Spinal System. The Tita Connectors are intended to be used with the other components of the Xia Titanium Spinal System.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
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)
signature
Page 1 of
and Neurological Devices
510(k) Number_