(185 days)
Not Found
No
The document describes a physical implant device and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
This device is a therapeutic device because its intended use is to treat degenerative disc disease and facilitate spinal fusion.
No
The device is an implant used for spinal fusion, not for diagnosing medical conditions. Its purpose is therapeutic, to facilitate fusion in patients with degenerative disc disease.
No
The device description clearly states that the device is a physical implant made from PEEK or Titanium alloy, intended for surgical implantation in the lumbar spine. It 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Curiteva Lumbar Interbody Fusion System is a surgical implant designed to be placed within the body (specifically, the lumbar spine) to facilitate bone fusion. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
The provided information clearly describes a medical device used for surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Curiteva Lumbar Interbody Fusion is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 - S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment prior to treatment with the device.
Product codes
MAX
Device Description
The Curiteva Lumbar Interbody Fusion System implants are available in a variety of different footprints, styles and sizes to accommodate surgical approach, and the individual pathology and anatomical conditions of the patient.
The implants are generally rectangle-shaped with an open central chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.
The Curiteva Lumbar Interbody Fusion System implants are manufactured from PEEK (per ASTM F2026) with Tantalum markers (per ASTM F560), or Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The PEEK implants are available with or without a medical grade commercially pure titanium (CpTi) plasma coating (per ASTM F1580) on the superior and inferior surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic studies
Anatomical Site
L2 - S1
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 Curiteva Lumbar Interbody Fusion System was mechanically tested in the following test modes: static and dynamic axial compression per ASTM F2077, static and dynamic compression-shear per ASTM F2077, subsidence per ASTM F2267, expulsion, and wear debris characterization per ASTM F1877.
The results of this non-clinical testing show that the strength and performance of the Curiteva Lumbar Interbody Fusion System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081614, K170395, K130573, K141953
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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December 20, 2018
Curiteva, LLC Eric Linder Chief Operating Officer 25127 Will McComb Drive, Suite 100 Tanner, Alabama 35671
Re: K181589
Trade/Device Name: Curiteva Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 27, 2018 Received: November 29, 2018
Dear Eric Linder:
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
1
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,
Katherine D. Kavlock -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) K181589
Device Name
Curiteva Lumbar Interbody Fusion System
Indications for Use (Describe)
The Curiteva Lumbar Interbody Fusion is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 - S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment prior to treatment with the device.
| 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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K181589 Page 1 of 2
510(k) Summary
A. Submitter Information
| Submitter: | Curiteva, LLC
25127 Will McComb Drive
Tanner, AL 35671
Phone: (256) 213-1057
Fax: (256) 213-1058 |
|-----------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eric Linder
regulatory@curiteva.com |
| Date Prepared: | November 27, 2018 |
B. Device Information
| Trade Name: | Curiteva Lumbar Interbody Fusion System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device Classification: | Class II (per 21 CFR 888.3080) |
| Product Code: | MAX |
| Classification Panel: | Division of Orthopedic Devices |
| Predicate Device(s): | Primary: Interbody Innovations, LLP Zeus Small Cervical Cage |
| and Large, Extra Large, Curved and Straight Lumbar Cages – | |
| K081614 | |
| Additional: Meditech Spine, LLC Talos Lumbar (HA) PEEK IBF | |
| Devices – K170395 | |
| Additional: Tyber Medical, LLC Interbody System – ACIF, ALIF, | |
| PLIF, TLIF, and DLIF – K130573 | |
| Additional: Titan Spine, LLC Endoskeleton® System | |
| (Endoskeleton® TA Interbody Fusion Device, Endoskeleton® | |
| TAS Interbody Fusion Device, Endoskeleton® TO Interbody | |
| Fusion Device, Endoskeleton® TT Interbody Fusion Device, | |
| Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TL | |
| Interbody Fusion Device, Endoskeleton® TA Vertebral Body | |
| Replacement) – K141953 |
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C. Device Description
The Curiteva Lumbar Interbody Fusion System implants are available in a variety of different footprints, styles and sizes to accommodate surgical approach, and the individual pathology and anatomical conditions of the patient.
The implants are generally rectangle-shaped with an open central chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.
The Curiteva Lumbar Interbody Fusion System implants are manufactured from PEEK (per ASTM F2026) with Tantalum markers (per ASTM F560), or Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The PEEK implants are available with or without a medical grade commercially pure titanium (CpTi) plasma coating (per ASTM F1580) on the superior and inferior surfaces.
D. Indications for Use
The Curiteva Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 - S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment prior to treatment with the device.
E. Technological Characteristics
As was established in this submission, the subject Curiteva Lumbar Interbody Fusion is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and to have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.
F. Performance Data
The Curiteva Lumbar Interbody Fusion System was mechanically tested in the following test modes: static and dynamic axial compression per ASTM F2077, static and dynamic compressionshear per ASTM F2077, subsidence per ASTM F2267, expulsion, and wear debris characterization per ASTM F1877.
The results of this non-clinical testing show that the strength and performance of the Curiteva Lumbar Interbody Fusion System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.