(79 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a spinal fixation system intended to stabilize spinal segments as an adjunct to fusion, rather than a therapeutic device that actively treats disease or provides therapy.
No
The text describes the device as a "Spinal Fixation System" intended to provide "immobilization of spinal segments as an adjunct to fusion" and "restore the integrity of the spinal column." This clearly indicates it is a surgical implant designed for treatment and structural support, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components made of Titanium alloy, such as screws, hooks, rods, and plates.
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 designed to provide mechanical support and stabilization to the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, hooks, rods, and plates made of titanium alloy. These are surgical instruments and implants, not reagents, analyzers, or other components typically associated with IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
The device is a spinal fixation system, which falls under the category of medical devices used for surgical intervention and support.
N/A
Intended Use / Indications for Use
The intended use of the Certex Spinal Fixation System is to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
- Instability or deformity;
- · Failed previous fusions (e.g., pseudoarthrosis);
- · Tumors involving the cervical/thoracic spine; and
· Degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The X-spine Certex Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The X-spine Certex Spinal Fixation System can be linked to X-spine Fortex® Pedicle Screw System and X-spine Xpress™ Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The Certex Spinal Fixation System consists of polyaxial screws, hooks, rods, occipital plates, occipital bone screws, cross bar connectors, lateral offset connectors and rod-to-rod connectors. System components can be connected and locked together to promote fusion of the occipitocervico-thoracic spine (Occiput-T3). System components are offered in various sizes and configurations to accommodate variations in pathology and individual patient anatomy. All Certex Spinal Fixation System components are manufactured from Titanium alloy (Ti6AI4V) in accordance with ASTM F136.
The purpose of this submission is to expand the indications of the Certex Spinal Fixation System to include cervical pedicle screw indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3), occipitocervico-thoracic spine (Occiput-T3)
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)
Performance testing and a detailed literature search indicates the Certex Spinal Fixation System is as mechanically sound as predicate devices. Testing included static compression, static torsion, dynamic compression, and dynamic torsion per a modified version of ASTM F1717, ASTM F2706 and sub-assembly testing in ASTM F1798. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
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.
Aesculap S4 Cervical Occipital Plate Spinal System (K151938), Certex Spinal Fixation System (K133094, K122163)
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2016
X-spine Systems, Incorporated % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005
Re: K160428
Trade/Device Name: Certex Spinal Fixation System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: February 29, 2016 Received: March 4, 2016
Dear Mr. Eggleton:
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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160428
Device Name Certex Spinal Fixation System
Indications for Use (Describe)
The intended use of the Certex Spinal Fixation System is to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
- Instability or deformity;
- · Failed previous fusions (e.g., pseudoarthrosis);
- · Tumors involving the cervical/thoracic spine; and
· Degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The X-spine Certex Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The X-spine Certex Spinal Fixation System can be linked to X-spine Fortex® Pedicle Screw System and X-spine Xpress™ Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.
Type of Use (Select one or both, as applicable) 2 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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
| Device Trade Name: | Certex Spinal Fixation System |
|---|---|
| Manufacturer: | X-spine Systems, Inc. |
| 452 Alexandersville Rd. | |
| Miamisburg, OH 45342 | |
| Contact: | Kriss Anderson |
| Regulatory Affairs Director | |
| Phone: (937) 847-8400 x137 | |
| kanderson@x-spine.com | |
| Prepared by: | Mr. Justin Eggleton |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (571) 276-2137 | |
| jeggleton@mcra.com | |
| Date Prepared: | April 27, 2016 |
| Classifications: | Unclassified |
| Class: | Unclassified |
| Product Codes: | NKG, KWP |
| Primary Predicate: | Aesculap S4 Cervical Occipital Plate Spinal System (K151938) |
| Additional Predicates: | Certex Spinal Fixation System (K133094, K122163) |
| Aesculap S4 Cervical Occipital Plate Spinal System (K151938) |
Indications For Use:
The intended use of the Certex Spinal Fixation System is to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
- Traumatic spinal fractures and/or traumatic dislocations; •
- Instability or deformity; •
- Failed previous fusions (e.g., pseudoarthrosis); .
- Tumors involving the cervical/thoracic spine; and .
5
- Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or . arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The X-spine Certex Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The X-spine Certex Spinal Fixation System can be linked to X-spine Fortex® Pedicle Screw System and X-spine Xpress™ Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.
Device Description:
The Certex Spinal Fixation System consists of polyaxial screws, hooks, rods, occipital plates, occipital bone screws, cross bar connectors, lateral offset connectors and rod-to-rod connectors. System components can be connected and locked together to promote fusion of the occipitocervico-thoracic spine (Occiput-T3). System components are offered in various sizes and configurations to accommodate variations in pathology and individual patient anatomy. All Certex Spinal Fixation System components are manufactured from Titanium alloy (Ti6AI4V) in accordance with ASTM F136.
The purpose of this submission is to expand the indications of the Certex Spinal Fixation System to include cervical pedicle screw indications.
Predicate Device:
The subject Certex Spinal Fixation System is substantially equivalent to predicate devices Certex Spinal Fixation System (K133094, K122163), and Aesculap S4 Cervical Occipital Plate Spinal System (K151938)) with respect to indications, design, function, and performance.
Summary of Technological Characteristics:
Certex Spinal Fixation System and the primary predicate, Aesculap S4 Cervical Occipital Plate Spinal System (K151938), are similar in indications for use, design, material, function, and performance. Additional comparisons were made to alternate predicate devices with the same indications for use, design, material, function, and performance.
Performance Testing:
Performance testing and a detailed literature search indicates the Certex Spinal Fixation System is as mechanically sound as predicate devices. Testing included static compression, static torsion, dynamic compression, and dynamic torsion per a modified version of ASTM F1717, ASTM F2706 and sub-assembly testing in ASTM F1798. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
6
Conclusion:
The 510(k) demonstrates substantial equivalence to the predicate devices cited in this summary.