(37 days)
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as "implants" designed to provide "stabilization as an adjunct to cervical fusion" for various spinal conditions, indicating it is used to treat medical conditions.
No
The device is described as an implant system (plates and screws) for stabilization in cervical fusion, which is a treatment, not a diagnostic process.
No
The device description explicitly states that the Struxxure® System consists of "plates and screws in a variety of sizes," which are physical hardware components. The performance studies also focus on the mechanical properties of these components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Struxxure® System is for "anterior screw fixation of the cervical spine" and provides "stabilization as an adjunct to cervical fusion." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details plates and screws, which are physical components implanted into the body.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or components.
The Struxxure® System is a surgical implant used for spinal fixation.
N/A
Intended Use / Indications for Use
The Struxxure® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Product codes
KWQ
Device Description
Struxxure consists of plates and screws in a variety of sizes. Plates from 1- to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-tapping and self-drilling versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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)
Static and dynamic compression bending and static torsion per ASTM F1717 was used to characterize the mechanical properties of the Struxxure® components. The mechanical test results demonstrate Struxxure® to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Blade® Anterior Cervical Plate System (K091936), C-Tek® MaxAn™ Anterior Cervical Plate System (K080646), ABC2 Cervical Plating System (K050813)
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.
0
Section 8 – 510(k) Summary
| Date: | 8 November 2013 |
|---|---|
| Sponsor: | Nexxt Spine |
| 14425 Bergen Blvd, Suite B | |
| Noblesville, IN 46060 | |
| Office: 317.436.7801 | |
| Fax: 317.245.2518 | |
| Contact Person: | Eric Lintula, Director of Engineering and Regulatory Affairs |
| Trade Names: | Struxxure® |
| Device Classification | Class II |
| Classification Name: | Appliance, fixation, spinal intervertebral body |
| Regulation: | 888.3060 |
| Device Product | |
| Code: | KWQ |
| Submission Purpose: | This submission adds the Struxxure® components to the Blade® |
| System of cervical solutions. | |
| Device Description: | Struxxure consists of plates and screws in a variety of sizes. |
| Plates from 1- to 5-levels are offered. Fixed and variable angle | |
| screws are available in two diameters in both self-tapping and self- | |
| drilling versions. | |
| Intended Use: | The Struxxure® System is intended for anterior screw fixation of |
| the cervical spine. These implants have been designed to provide | |
| stabilization as an adjunct to cervical fusion. Indications for the use | |
| of this implant system include degenerative disc disease (defined | |
| as neck pain of discogenic origin with the degeneration of the disc | |
| confirmed by history and radiographic studies), spondylolisthesis, | |
| trauma (i.e., fractures or dislocations), spinal stenosis, deformity | |
| (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or | |
| failed previous fusion. | |
| Materials: | Struxxure plates and screws are manufactured from titanium |
| (Grade 4) or titanium alloy (Ti-6Al-4V ELI) as described by ASTM | |
| F67 and ASTM F136, respectively. | |
| Predicate Devices: | Blade® Anterior Cervical Plate System (K091936)' |
| C-Tek® MaxAn™ Anterior Cervical Plate System (K080646) | |
| ABC2 Cervical Plating System (K050813) | |
| Performance Data: | Static and dynamic compression bending and static torsion per |
| ASTM F1717 was used to characterize the mechanical properties | |
| of the Struxxure® components. The mechanical test results | |
| demonstrate Struxxure® to be substantially equivalent to the | |
| predicate devices. |
.
:
.
1
Technological Characteristics:
The Struxxure® components possess the same technological characteristics as the predicates. These include:
- basic design (plate and screw fixation system), .
- material (titanium and titanium alloy), .
- sizing: sizes (diameter and lengths) are within the range of . those offered in the predicate systems, and
- . anatomic location.
Therefore the fundamental scientific technology of the Struxxure® System is the same as previously cleared devices.
In comparison to the predicate devices, the Struxxure® Cervical Plates and Screws have
- the same intended use (as described above), .
- the same technological characteristics (as described above) .
Therefore the Struxxure® System can be found substantially equivalent to the predicate devices.
Conclusion:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three arms or extensions reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2013
Nexxt Spine LLC Mr. Eric Lintula Director of Engineering and Regulatory Affairs 14425 Bergen Boulevard. Suite B Noblesville, Indiana 46060
Re: K133475
Trade/Device Name: Struxxure® Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 22, 2013 Received: November 25. 2013
Dear Mr. Lintula:
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 does 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 either 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
3
Page 2 - Mr. Eric Lintula
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 7 - Indications for Use Statement
510(k) Number: K133475
Device Name: Struxxure®
Indications for Use:
The Struxxure® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Prescription Use X
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of