(212 days)
Not Found
No
The summary describes a mechanical vertebral body replacement device and its delivery system. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
A therapeutic device intends to treat or cure a disease or condition. This device is a vertebral body replacement, which is a structural implant, not a therapeutic agent.
No
The device is a vertebral body replacement system, an implant used in surgery to replace or restore vertebral height, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a vertebral body replacement device composed of physical components (wafers, expandable implant, delivery device) made from PEEK-OPTIMA with Barium Sulfate, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace a vertebral body in the spine due to tumor or trauma. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of PEEK material, designed to be surgically placed. This is consistent with a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or using reagents or assays, which are hallmarks of IVD devices.
Therefore, the StaXx™ XD System is a medical device, specifically a vertebral body replacement device, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The StaXx™ XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXxTM XD System is the Stryker Xia® Spinal System.
Product codes
MQP
Device Description
The StaXxTM XD System is a vertebral body replacement device composed of wafers that are stacked into an expandable implant to adjust its height. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to implant and expand the system. The device is offered in sizes ranging from 7mm to 30mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
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 demonstrated that the StaXx™ XD System meets the performance requirements for its intended that the BlaAx - AD bystem moos any M XD System and the predicate devices do not affect the safety or effectiveness of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043566, K041939, K033702, K031757, K040284, K033303
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the words "Spine Wave" in a bold, sans-serif font. A curved line runs beneath the words, starting below the 'W' in 'Wave' and extending to the left, under the 'S' in 'Spine'. The text and the line are both black, contrasting with the white background.
510(k) Summary StaXx™ XD System
APR 2 7 2006
I. Submitter Information
Spine Wave, Inc.
Two Enterprise Drive
Suite 302
Shelton, CT 06484
| Telephone: | 203-944-9494 |
|---|---|
| Telefax: | 203-944-9493 |
| Contact: | Ronald K. Smith |
|---|---|
| Date Prepared: | March 5, 2006 |
II. Device Information
| Trade name: | StaXx™ XD System |
|---|---|
| Common name: | Vertebral Body Replacement |
| Classification: | Class II per 21 CFR 888.3060 |
| Classification Name: | Spinal Intervertebral Fixation Orthosis |
| Product Code: | MQP |
III. Device Information
The StaXxTM XD System is a vertebral body replacement device composed of wafers that are stacked into an expandable implant to adjust its height. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to implant and expand the system. The device is offered in sizes ranging from 7mm to 30mm.
IV. Intended Use
The StaXx™ XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXxTM XD System is the Stryker Xia® Spinal System.
V. Substantial equivalence
The StaXx™ XD System was demonstrated to be substantially equivalent to the VERTE-STACKTM Spinal System (Medtronic Sofamor Danek, K043566), the Blackstone™ PEEK VBR System (Blackstone Medical, Inc., K041939 and K033702), the PEEK Tetris™ System (SIGNUS Medical LLC, K031757), the Sustain Radiolucent Spacer (Globus Medical Inc., K040284) and The Wafer System (Spine Wave, K033303). In addition, mechanical testing demonstrated
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KC52670
Page 2 of 2
that the StaXx™ XD System meets the performance requirements for its intended that the BlaAx - AD bystem moos any M XD System and the predicate devices do not affect the safety or effectiveness of this 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 caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR . 7 2006
Spine Wave, Inc. c/o Mr. Ronald K. Smith Director, Quality and Regulatory Affairs Two Enterprise Drive, Suite 302 Shelton, Connecticut 06484
Re: K052670
Trade/Device Name: StaXxTM XD System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP Dated: January 26, 2006 Received: January 27, 2006
Dear Mr. Smith:
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 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
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Page 2 - Mr. Ronald K. Smith
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 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" (21 CFR 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,
Marli A. Milhiss
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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A. Indications for Use
510(k) Number (if known):
StaXx™ XD System Device Name:
Indications for Use:
The StaXx™ XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXxTM XD System is the Stryker Xia® Spinal System.
r Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH/Office of Device Evaluation (ODE)
Allala Mckeen
(Print Name of Officer)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K0526