(90 days)
Not Found
No
The summary describes a physical medical device (an interbody fusion system) and its intended use, materials, and fixation methods. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies described are engineering tests comparing the device's mechanical properties.
Yes
The device is described as a cervical intervertebral fusion system used to treat various conditions like degenerative disc disease, trauma, and spinal stenosis, with the goal of facilitating fusion. This aligns with the definition of a therapeutic device which aims to treat or prevent disease or injury.
No
This device is a fusion system, intended to facilitate spinal fusion and provide fixation, not to diagnose medical conditions.
No
The device description clearly describes a physical interbody cage made of titanium alloy with integrated screws or anchors, intended for surgical implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The SPIRA®-C Integrated Fixation System is a surgical implant (an interbody fusion system) designed to be placed directly into the cervical spine to facilitate bone fusion. It is a physical device used in the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating various conditions of the cervical spine by promoting fusion. This is a therapeutic intervention, not a diagnostic test.
Therefore, based on the provided information, the SPIRA®-C Integrated Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SPIRA®-C Integrated Fixation System is intended for use as a cervical intervertebral fusion system indicated for use at one or two contiguous levels in the cervical spine (C2-T1), in skeletally mature patients who have had six weeks of non-operative treatment for the following: degenerative disc disease (DDD, defined as neck pain with degeneration of the disc confirmed by patient history and radiographic studies), cervical spondylotic myelopathy, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), pseudarthrosis, and failed previous fusion. The device is intended for use with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
When used with screws, SPIRA®-C Integrated Fixation System are standalone interbody fusion devices intended for use at one or two contiguous levels in the cervical spine (C2-T1). When used with anchors, SPIRA®-C Integrated Fixation System is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.
Product codes
OVE
Device Description
The SPIRA®-C Integrated Fixation System cages are interbody cages with integrated screws to provide additional fixation in interbody fusion procedures. The subject submission seeks to add anchors as an option for use for integrated fixation. The SPIRA-C® Integrated Fixation System cages are provided various heights and footprints to accommodate patient anatomy. The SPIRA®-C Integrated Fixation System has spiral supports to allow for a hollow chamber to permit packing with bone graft to facilitate fusion. This device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The titanium alloy interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. When used with screws as integrated fixation, SPIRA-C Integrated Fixation is a stand-alone cervical fixation device. However, this submission seeks to add anchors as another option for integrated fixation. When used with anchors, the SPIRA-C Integrated Fixation System must be used with supplemental fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1)
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)
An engineering rationale was provided to demonstrate that SPIRA®-C Integrated Fixation System with anchors does not introduce a new worst-case when compared to the previously cleared interbody and screw construct as well as the non-integrated SPIRA®-C cage.
Testing, through the use of Finite Element Analysis (FEA) simulations, shows that the anchors are equivalent to the screw-based construct and has less internal stress than the non-integrated SPIRA® -C Open Matrix cage. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K172446, K193153, K173115, K202065, K191243, K222270
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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March 22, 2023
Camber Spine Technologies % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112
Re: K223837
Trade/Device Name: SPIRA®-C Integrated Fixation System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: January 25, 2023 Received: January 26, 2023
Dear Christine Scifert:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223837
Device Name SPIRA®-C Integrated Fixation System
Indications for Use (Describe)
The SPIRA®-C Integrated Fixation System is intended for use as a cervical intervertebral fusion system indicated for use at one or two contiguous levels in the cervical spine (C2-T1), in skeletally mature patients who have had six weeks of non-operative treatment for the following: degenerative disc disease (DDD, defined as neck pain with degeneration of the disc confirmed by patient history and radiographic studies), cervical spondylotic myelopathy, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), pseudarthrosis, and failed previous fusion. The device is intended for use with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
When used with screws, SPIRA®-C Integrated Fixation System are standalone interbody fusion devices intended for use at one or two contiguous levels in the cervical spine (C2-T1). When used with anchors, SPIRA®-C Integrated Fixation System is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary Camber SPIRA®-C Integrated Fixation System 16 March 2023
| Company: | Camber Spine Technologies
501 Allendale Rd
King of Prussia, PA 19406
(484) 427-7060 |
|-------------------------|----------------------------------------------------------------------------------------------|
| Company Contact: | Brooks McAdam
VP of Operations
(484) 427-7060
bmcadam@cambermedtech.com |
| Official Correspondent: | Christine Scifert – MRC Global, LLC
Christine.scifert@askmrcglobal.com
901-831-8053 |
| Trade Name: | SPIRA®-C Integrated Fixation System |
| Common Name: | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) |
| Panel: | Orthopedic |
| Product Code: | OVE |
Device Description:
The SPIRA®-C Integrated Fixation System cages are interbody cages with integrated screws to provide additional fixation in interbody fusion procedures. The subject submission seeks to add anchors as an option for use for integrated fixation. The SPIRA-C® Integrated Fixation System cages are provided various heights and footprints to accommodate patient anatomy. The SPIRA®-C Integrated Fixation System has spiral supports to allow for a hollow chamber to permit packing with bone graft to facilitate fusion. This device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The titanium alloy interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. When used with screws as integrated fixation, SPIRA-C Integrated Fixation is a stand-alone cervical fixation device. However, this submission seeks to add anchors as another option for integrated fixation. When used with anchors, the SPIRA-C Integrated Fixation System must be used with supplemental fixation.
4
Indications for Use:
The SPIRA®-C Integrated Fixation System is intended for use as a cervical intervertebral fusion system indicated for use at one or two contiguous levels in the cervical spine (C2-T1), in skeletally mature patients who have had six weeks of non-operative treatment for the following: degenerative disc disease (DDD, defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), cervical spondylotic myelopathy, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), pseudarthrosis, and failed previous fusion. The device is intended for use with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
When used with screws, SPIRA®-C Integrated Fixation System are standalone interbody fusion devices intended for use at one or two contiguous levels in the cervical spine (C2-T1). When used with anchors, SPIRA®-C Integrated Fixation System is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.
Substantial Equivalence:
The subject SPIRA® C Integrated Fixation System is substantially equivalent to the following predicate devices:
Primary Predicate(s):
Camber Spine Technologies - SPIRA®-C Open Matrix Cervical Interbody (K172446)
Additional Predicate(s):
Camber Spine Technologies - SPIRA®-C Integrated Fixation System (K193153) Globus Medical - COALITION MIS® (K173115) Astura Medical - DOLOMITE Anterior Cervical Stabilization System (K202065) Glubus Medical - HEDRON Cervical Spacer (K191243, K222270)
The same SPIRA®-C Integrated Fixation System interbody device, previously submitted in K193153 for use with screws, is used in this Premarket 510(k) Notification. The anchors are manufactured from the same Titanium Alloy (Ti-6Al-4V ELI) and cover the same range of sizes (12-18mm). The Indications for Use will be changing for the anchors in this submission when compared to the original SPIRA®-C Integrated Fixation System submission. The anchors will not have standalone indications and require supplemental fixation, similar to the SPIRA®-C Open Matrix Cervical system submitted in K172446. Testing, through the use of Finite Element Analysis (FEA) simulations, shows that the anchors are equivalent to the screw-based construct and has less internal stress than the non-integrated SPIRA® -C Open Matrix cage. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
An engineering rationale was provided to demonstrate that SPIRA®-C Integrated Fixation System with anchors does not introduce a new worst-case when compared to the previously cleared interbody and screw construct as well as the non-integrated SPIRA®-C cage.
Conclusion:
Based on the engineering rationale and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.