(135 days)
Not Found
No
The 510(k) summary describes a mechanical interbody fusion device and its associated instruments. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for "spinal intervertebral body fusion" to treat "degenerative disc disease," which is a medical condition. Its function includes "structural stability for interbody fusion," "restore intervertebral disc height," and "provide anterior column support," all aimed at alleviating a medical condition.
No
This device is an implantable interbody fusion device intended for spinal fusion, not for diagnosing conditions.
No
The device description clearly states it is an expandable lumbar intervertebral body fusion device consisting of a shell and a shim component, and includes manual surgical instruments. This indicates a physical implant and associated hardware, not a software-only device.
Based on the provided information, the FlareHawk™ Interbody Fusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for spinal intervertebral body fusion, a surgical procedure to treat degenerative disc disease. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical implant (expandable lumbar intervertebral body fusion device) designed to be surgically placed within the spine. It is used with bone graft and supplemental fixation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The FlareHawk™ system does not perform any such analysis of biological specimens.
- Anatomical Site: The device is used within the spine, not for testing biological samples.
Therefore, the FlareHawk™ Interbody Fusion System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
FlareHawk™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/ or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk™ system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Product codes
MAX
Device Description
Integrity Implants' FlareHawk™ Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk™ interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk™ device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk™ interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk™ interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk™ Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation. FlareHawk™ Interbody Fusion System implant and instrument devices are supplied non-sterile and are intended for steam sterilization by the user prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine from L2 to S1
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
Prescription Use
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 was conducted according to FDA guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices", and the following standards:
- ASTM F2077: Test Methods for Intervertebral Body Fusion Devices
- Static Compression
- Static Compression-Shear
- Dynamic Compression
- Dynamic Compression-Shear
- ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of the Intervertebral Body Fusion Device under Static Axial Compression
Key results: Based on the mechanical testing and other supporting documentation provided in this premarket notification, the subject FlareHawk™ Interbody Fusion System demonstrates substantial equivalence to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K133514, K160076, K150395, K160924, K072970, K102293
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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Integrity Implants Inc Lauren Kamer Director of Regulatory 850 Parkway Street Jupiter, Florida 33477
Re: K183184
Trade/Device Name: FlareHawk™ Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 1, 2019 Received: March 4, 2019
Dear Ms. Kamer:
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.
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
April 3, 2019
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183184
Device Name
FlareHawk™ Interbody Fusion System
Indications for Use (Describe)
FlareHawk™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/ or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk™ system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
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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FlareHawk™ Interbody Fusion System 510(k) Summary
March 1, 2019
| I. | Company: | Integrity Implants Inc |
|---|---|---|
| 850 Parkway | ||
| Jupiter, FL 33477 USA | ||
| Telephone: (561) 529-3861 | ||
| FAX: (561) 529-3869 | ||
| II. | Contact: | Lauren Kamer |
| Director of Regulatory | ||
| III. | Proprietary Trade Name: | FlareHawk™ Interbody Fusion System |
| IV. | Common Name: | Intervertebral Body Fusion Device |
| with Bone Graft, Lumbar | ||
| V. | Classification Name: | Intervertebral Body Fusion Device (21 CFR 888.3080) |
| Class: | II |
VI. Product Description
Integrity Implants' FlareHawk™ Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk™ interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk™ device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk™ interbody fusion device is designed to restore intervertebral disc height,
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provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk™ interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk™ Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation. FlareHawk™ Interbody Fusion System implant and instrument devices are supplied non-sterile and are intended for steam sterilization by the user prior to use.
VII. Indications for Use
FlareHawk™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk™ system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
VIII. Summary of Technological Characteristics
The subject FlareHawk™ Interbody Fusion System has the same fundamental scientific technology as the predicate FlareHawk™ Interbody Fusion System. Like the predicate FlareHawk™ Interbody Fusion System, the shell component of the subject FlareHawk™ Interbody Fusion System implants is a rectangular frame that is inserted into the disc space in a non-expanded form, with subsequent in-situ expansion resulting from the insertion of the shim component. The shell component is manufactured from PEEK per ASTM F2026. The shell component incorporates an integrated core manufactured from titanium alloy per ASTM F136, and tantalum markers per ASTM F560 for imaging purposes. The shell component features a bulleted nose designed to facilitate ease of insertion, as well as directional teeth on its superior and inferior surfaces to resist expulsion. Like the predicate FlareHawk™
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Interbody Fusion System, the shim component of the subject FlareHawk™ Interbody Fusion System implants has a tapered front end that inserts into and expands the shell component to the desired height and lordosis. The shim is manufactured from titanium alloy per ASTM F136 and the shims are color anodized by size. The shim locks to both the shell core and the posterior of the shell when the implant is deployed.
IX. Identification of Legally Marketed Predicate Devices Used to Claim Substantial Equivalence
To demonstrate the substantial equivalence of the subject FlareHawk™ Interbody Fusion System to legally marketed predicate devices, FlareHawk™ Interbody Fusion System, K133514 (SE 05/01/2014) and K160076 (SE 10/13/2016), is used as the primary predicate device.
Additional predicates are Amendia/Spinal Elements' OmegaLIF™ System, K150395 (SE 08/10/2015) and K160924 (SE 11/08/2016), Globus Medical's PATRIOT® Spacers, K072970 (SE 01/18/2008), and Globus Medical's CALIBER® Spacers K102293 (SE 01/05/2011).
X. Brief Discussion of the Non-Clinical Tests Submitted
Mechanical testing was conducted according to FDA guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices", and the following standards:
- . ASTM F2077: Test Methods for Intervertebral Body Fusion Devices
- Static Compression o
- o Static Compression-Shear
- Dynamic Compression o
- Dynamic Compression-Shear o
- . ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of the Intervertebral Body Fusion Device under Static Axial Compression
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XI. Conclusions Drawn for the Non-Clinical Tests
Based on the mechanical testing and other supporting documentation provided in this premarket notification, the subject FlareHawk™ Interbody Fusion System demonstrates substantial equivalence to legally marketed predicate devices including the previously cleared FlareHawk™ Interbody Fusion System, Amendia/Spinal Elements' OmegaLIF™ System, Globus Medical's PATRIOT® Spacers, and Globus Medical's CALIBER® Spacers.