(29 days)
No
The document describes a spinal implant system made of titanium components and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat various spinal conditions like spondylolisthesis, fracture, scoliosis, and tumors, indicating its therapeutic purpose.
No
The Xia Spinal System is a surgical implant designed for spinal stabilization and fusion, not for diagnosing medical conditions. Its intended use involves providing mechanical support and immobilization.
No
The device description explicitly lists physical components made of Titanium material (Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors, and Multi-Axial Cross Connectors). This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Xia Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information about a person's health.
- The Xia Spinal System is a surgical implant intended for fixation and stabilization of the spine. It is a physical device implanted into the body, not used to analyze biological samples.
The description clearly outlines its use in surgical procedures for treating spinal conditions, which falls under the category of a medical device, but not specifically an IVD.
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 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.
Product codes
KWP, KWQ, MNH, MNI
Device Description
This submission is intended to address a line extension to Xia® Spinal System. The line extension includes a new range of offset and rod to rod Titanium alloy connectors.
The Xia® Titanium Spinal System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs). The components are manufactured from Titanium material (Ti alloy and CP Titanium).
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 (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)
K013823, K013688, K002505, K043473
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
SEP - 8 2005
Image /page/0/Picture/2 description: The image shows the text "Special 510(k) Premarket Notification" along with the number K052181 at the top. The text is in a simple, sans-serif font, and the number is handwritten. The image appears to be a scan or photograph of a document.
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: | August 8, 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: | |
| K013823 Stryker Spine Xia Spinal System | |
| K013688 OSS and Opus Rods – Use with Xia | |
| Spinal System | |
| K002505 Line Extension - Xia Spine System | |
| K043473 Line Extension – Xia Spinal System |
Predicate Device Identification
I The Xia® Titanium Spinal System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs). The components are manufactured from Titanium material (Ti alloy and CP Titanium).
1
K052181 P2
Special 510(k) Premarket Notification
Description of Device Modification
This submission is intended to address a line extension to Xia® Spinal System. The line extension includes a new range of offset and rod to rod Titanium alloy connectors.
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: Xia Spinal System (K013823). Mechanical testing also demonstrated comparable mechanical properties to the predicate device.
3
Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES". The symbol in the center appears to be a stylized depiction of an eagle or bird with outstretched wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2005
Ms. Simona Voic RA Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401
Re: K052181 Trade/Device Name: Xia Spinal System Regulation Number: 21 CFR 888.3070 (b) (1) Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: KWP, KWQ, MNH, MNI Dated: August 8, 2005 Received: August 10, 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 for asservior 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 Cosmatic 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 Codc 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.
4
Page 2-Ms.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/industry/support/index.html.
Sincerely yours,
Mark A. Millizen
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K 052181
Device Name: Xia Spinal System
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 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 sacralfiliac 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 Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.
x 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
Mark Millan
(Division Sign-Off) al. Restorative, and Neurologica
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number _