(28 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments, treat severe spondylolisthesis, degenerative spondylolisthesis, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion, which are all conditions that require therapeutic intervention.
No
The device is a spinal fixation system used for surgical procedures, not for diagnosis.
No
The device description explicitly lists hardware components such as screws, washers, hooks, rods, and connectors, indicating it is a physical medical device system, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for spinal fixation and stabilization. It is used in vivo (within the body) during surgery.
- Device Description: The device components are described as screws, rods, hooks, connectors, etc., which are typical components of a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pcdicle screw fixation system, the Xia Stainless Steel 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 Stainless Steel 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 Stainless Steel 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, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
Product codes
KWP, KWQ, MNH, MNI
Device Description
The Xia Stainless Steel System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs). This submission is intended to address a line extension to the Xia Stainless Steel System. The line extension includes a new range of offset and rod to rod connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text reads 'kos1973' in a slightly stylized or cursive font. The letters 'kos' are followed by the numbers '1973', all written in black ink on a white background.
Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Xia Stainless Steel System
AUG 1 8 2005
| 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 | |
| Date of Summary Preparation: | July 20, 2005 |
| Device Identification | |
| Proprietary Name: | Xia Stainless Steel 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 Identification
The Xia Stainless Steel System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs).
Description of Device Modification
This submission is intended to address a line extension to the Xia Stainless Steel System. The line extension includes a new range of offset and rod to rod connectors.
Intended Use:
The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pcdicle screw fixation system, the Xia Stainless Steel 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 Stainless Steel 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 Stainless Steel System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc
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confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
Statement of Technological Comparison:
Statement of I components share the same intended use and basic design concepts as that of the r no bate device: Xia Stainless Steel System (K012870 and K031090). Mechanical testing also demonstrated comparable mechanical properties to the predicate device.
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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 wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2005
Ms. Simona Voic RA Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401
Re: K051973
Trade/Device Name: Xia Stainless Steel System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, KWQ, MNH, MNI Dated: July 20, 2005 Received: July 21, 2005
Dear Ms. Voic:
We have reviewed your Section 510(k) premarket notification of intent to market the device w Filtere a Prove 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 for use stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner to print of the provision 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 r ou may , mers, sportions 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 complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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Page 2-Ms. Simona Voic
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witi anow you to begin manical equivalence of your device of your device to a legally premitset notincation. The Privating of castion 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 If you desire specific advice for your as 0) 276-0120. Also, please note the regulation entitled, a comati the Office of Comphalled at (210) = if = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Mission of Icrerchee to premainer to premainter the Act from the Division of Small other general information on your responsive Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sr
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KOSA73______________________________________________________________________________________________________________________________________________
Device Name: Xia Stainless Steel System
Indications For Use:
The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a The Xia Grainless Stock of Stainless Steel System is intended for patients: (a) having pealule serville likelion bytem, the Ala Cla) at the fifth lumbar - first sacral (L5-S1) vertebral joint, severe spondylonomene (on asing autogenous bone graft only; (c) who are having the device (b) who are roosting rasimal 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 Stainless Steel System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an to provide in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence the therelore, 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 viton about an antener steel 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, tumor, pseudoarthrosis or revision of failed fusion attempts.
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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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510(k) Number_K051833