(49 days)
Not Found
No
The description focuses on the mechanical components and materials of the implant and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The devices are vertebral body and intervertebral body replacement/fusion devices intended to replace and restore height due to severe conditions like tumor, trauma, or degenerative disc disease, which are therapeutic interventions.
No
The device description clearly states that the StaXx® Systems are "expandable implants and interlocking wafers" intended to "replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof" or for "intervertebral body fusion procedures." These are therapeutic and structural support functions, not diagnostic ones.
No
The device description clearly states that the StaXx® Systems are composed of physical components including expandable implants, interlocking wafers, a delivery system (Cartridge and Surgical Gun), and are manufactured from materials like PEEK-OPTIMA and tantalum. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, the StaXx® Systems are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly describes the StaXx® Systems as implantable medical devices used to replace and restore height of vertebral bodies or for intervertebral body fusion in the spine. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device description details the physical components of the implants (expandable implants, wafers, delivery system) and the materials they are made from (PEEK-OPTIMA, Barium Sulfate, tantalum markers). This aligns with the description of a surgical implant.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on analysis of samples.
In summary, the StaXx® Systems are surgical implants used for structural support and fusion in the spine, which falls under the category of medical devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The StaXx® Systems have the following indications:
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 autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.
The StaXx® XDL 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 used with autograft or allograft and supplemental spinal fixation.
The StaXx® IB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IB System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Product codes (comma separated list FDA assigned to the subject device)
MQP, MAX
Device Description
The StaXx® Systems are composed of expandable implants and interlocking wafers, which are implanted through a delivery system that includes a Cartridge and a Surgical Gun. The Cartridge is inserted into the Surgical Gun which, when activated, sequentially delivers locking wafers from the Cartridge to the expandable implant. The wafers are designed to be inserted incrementally to form a stack and therefore attain the desired height.
The StaXx® XD and XDL Systems are vertebral body replacement devices intended for use in the thoracolumbar spine (TI-L5). They are composed of wafers that are stacked into an expandable implant 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 implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain tantalum markets for additional visualization under fluoroscopy. The StaXx® XD System is to be placed bilaterally while the StaXx® XDL System is to be placed unilaterally and both are to be used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.
The StaXx® IB and IBL Systems are intervertebral body fusion devices composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implants are to be used with autogenous bone graft material. The StaXx® IB implant components are manufactured from both PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate while the StaXx® IBL implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and tantalum markers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5), L2-S1, L2-L5
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)
The following non-clinical tests were performed to demonstrate that the subject StaXx® Systems are substantially equivalent to the listed predicate devices:
- Simulated Use Testing .
- . Insertion Testing
- . Cadaveric Testing
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.
K121889, K102315, K123461, K132719
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
§ 888.3060 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.
0
DEC 0 6 2013
SpineWAVE
510(k) Summary StaXx® System
1. Submitter Information
Submitter: Address:
Spine Wave, Inc. Three Enterprise Drive Suite 210 Shelton, CT 06484 Telephone: 203-712-1847 203-944-9493 Telefax:
Contact:
Joseph Mercado
Date Prepared: December 3, 2013
-
- Device Information Trade Name:
StaXx® System
- Device Information Trade Name:
Fusion Device
Common Name(s):
Classification Name(s):
Spinal Intervertebral Body Fixation Orthosis; Intervertebral Fusion Device with Bone Graft, Lumbar
Vertebral Body Replacement; Intervertebral Body
Classification(s)/Code(s):
Class II per 21 CFR 888.3060/MQP; Class II (special controls) per 21 CFR 888.3080/MAX
3. Purpose of Submission
The purpose of this submission is to gain clearance for a new Surgical Gun to be used with the StaXx® Systems.
4. Predicate Device Information
The StaXx® Systems described in this submission are substantially equivalent to the following predicates:
| Predicate Device | Manufacturer | Most recent
510(k) No. |
|-------------------|------------------|---------------------------|
| StaXx® XD System | Spine Wave, Inc. | K121889 |
| StaXx® XDL System | Spine Wave, Inc. | K102315 |
| StaXx® IB System | Spine Wave, Inc. | K123461 |
| StaXx® IBL System | Spine Wave, Inc. | K132719 |
1
5. Device Description
The StaXx® Systems are composed of expandable implants and interlocking wafers, which are implanted through a delivery system that includes a Cartridge and a Surgical Gun. The Cartridge is inserted into the Surgical Gun which, when activated, sequentially delivers locking wafers from the Cartridge to the expandable implant. The wafers are designed to be inserted incrementally to form a stack and therefore attain the desired height.
The StaXx® XD and XDL Systems are vertebral body replacement devices intended for use in the thoracolumbar spine (TI-L5). They are composed of wafers that are stacked into an expandable implant 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 implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain tantalum markets for additional visualization under fluoroscopy. The StaXx® XD System is to be placed bilaterally while the StaXx® XDL System is to be placed unilaterally and both are to be used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.
The StaXx® IB and IBL Systems are intervertebral body fusion devices composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implants are to be used with autogenous bone graft material. The StaXx® IB implant components are manufactured from both PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate while the StaXx® IBL implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and tantalum markers.
6. Intended Use
The StaXx® Systems have the following indications:
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 autograft or allografi and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.
The StaXx® XDL 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 used with autograft or allograft and supplemental spinal fixation.
2
The StaXx® IB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IB System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
7. Comparison of Technological Characteristics
The substantial equivalence of the StaXx® Systems to the predicates is shown by similarity in intended use, indications for use, materials and performance.
8. Performance Data
The following non-clinical tests were performed to demonstrate that the subject StaXx® Systems are substantially equivalent to the listed predicate devices:
- Simulated Use Testing .
- . Insertion Testing
- . Cadaveric Testing
9. Conclusion
Based on the indications for use, technological characteristics and comparison to the predicates, the subject StaXx® Systems have been shown to be substantially equivalent to the predicate devices identified in this submission, and do not present any new issues of safety or effectiveness.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2013
Spine Wave, Incorporated Mr. Joseph Mercado Regulatory Affairs Specialist 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K133207
Trade/Device Name: StaXx * Surgical Gun Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP, MAX Dated: November 5. 2013 Received: November 6, 2013
Dear Mr. Mercado:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Joseph Mercado
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiqqins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133207
Device Name StaXx(R) Surgical Gun
Indications for Use (Describe)
The StaXx® Systems have the following indications:
The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-LS) to replace and restore height of a collapsed, 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 autograft or allograft and supplemental fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System:
The StaXx® XDL System is a vertebral body replacement device in the thoracolumbar spine (TI-LS) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof. due to turnor or trauma (i.e., fracture), The system is to be used with autograft or allograft and supplemental spinal fixation.
The StaXx® IB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IB System is to be used with and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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| Concurrence of t | Center for I | *or Devices and Radiological Health (CDRH) i | |
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.