(198 days)
Not Found
No
The summary describes a mechanical implant device and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is an anterior cervical intervertebral body fusion device used to treat degenerative disc disease, which is a medical condition. This directly aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is an anterior cervical intervertebral body fusion device, meaning it is an implant designed for treatment, not diagnosis. It is used to fuse vertebrae after disc removal in patients with degenerative disc disease.
No
The device description explicitly states it is composed of a titanium cage and screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The C-CURVE® Device is an implantable surgical device designed to be inserted between vertebrae in the cervical spine. It is a physical device used for structural support and fusion, not for testing biological samples.
- Intended Use: The intended use is for anterior cervical intervertebral body fusion in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The C-CURVE® Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate. The device is a stand-alone system when used C-Curve screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
OVE, ODP
Device Description
MEDICREA® INTERNATIONAL S.A. C-CURVE® is composed of a cervical cage range stabilized by C-CURVE® screws. The titanium cage is composed of two pre-assembled components (the cage body and an expansion screw) that enable its expansion and adaptation of its lordotic angle. The cages are delivered individually and the screws are provided separately by two. The cages are available in different footprints and heights. These implants are designed to be inserted between two adjacent cervical vertebrae after removal of the disc. C-CURVE® is implanted by anterior approach. It is important to refer to the surgical technique and to the Instructions For Use (see paragraph «IMPLANT INSERTION», especially to use the two screws to stabilize the cage). C-CURVE® can be considered as a stand-alone cage if the two screws are used to stabilize the cage. If it is not the case, an additional fixation system must be added. Titanium cages & screws are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications. Under no circumstances are the implants reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to T1)
Indicated Patient Age Range
skeletally mature patients
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)
Non-clinical Test Summary:
Biocompatibility Testing: The C-Curve components are made from the same materials as its predicates and the manufacturing processes are similar to the ones of the predicates.
Mechanical testing: The tests performed on the C-Curve components (Static & Dynamix Axial Compression, Static & Dynamic Torsion, Static and Dynamic Compression Shear per ASTM F2077 , Subsidence per ASTM F2267 and Postero-anterior expulsion) indicate that the product is mechanically equivalent to its predicates.
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.
K192018, K192570, K073285, K153373, K132894
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
§ 888.3080 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 3, 2021
Medicrea International S. A. Karine Trogneux Regulatory Affairs Department Manager 5389 route de Strasbourg - Vancia Rillieux-La-Pape, 69140 France
Re: K210470
Trade/Device Name: C-CURVE Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: July 23, 2021 Received: August 4, 2021
Dear Karine Trogneux:
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
1
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,
Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210470
Device Name C-CURVE
Indications for Use (Describe)
The C-CURVE® Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate. The device is a stand-alone system when used C-Curve screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
The Company's 510(k) Summary is provided on the following pages.
510(k) SUMMARY MEDICREA INTERNATIONAL's C-Curve
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the C-Curve:
Date Prepared: February, 15, 2021 Prepared answers: July, 23, 2021
1. Submitter:
MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR
Contact Person:
Karine Trogneux MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR
2. Trade name: C-Curve
Regulatory Identification/ Classification
Intervertebral Fusion Device With Integrated Fixation, Cervical / Intervertebral Fusion Device With Bone Graft, Cervical Regulation Number: 21CFR 888.3080 Product Code: OVE, ODP Class II
3. Predicate or legally marketed devices which are substantially equivalent:
Primary predicate device:
- Endoskeleton TCS Interbody Fusion Device (Titan Spine, K192018)
Additional predicate devices:
- HIJAK SA (Atlas Spine, K192570)
- PEEK Prevail (Medtronic, K073285, K153373)
- Optio-C (ZIMMER SPINE, K132894)
None of those devices have not been subject to a design-related recall.
4
4. Description of the device:
MEDICREA® INTERNATIONAL S.A. C-CURVE® is composed of a cervical cage range stabilized by C-CURVE® screws. The titanium cage is composed of two pre-assembled components (the cage body and an expansion screw) that enable its expansion and adaptation of its lordotic angle. The cages are delivered individually and the screws are provided separately by two. The cages are available in different footprints and heights. These implants are designed to be inserted between two adjacent cervical vertebrae after removal of the disc. C-CURVE® is implanted by anterior approach. It is important to refer to the surgical technique and to the Instructions For Use (see paragraph «IMPLANT INSERTION», especially to use the two
screws to stabilize the cage). C-CURVE® can be considered as a stand-alone cage if the two screws are used to stabilize the cage. If it is not the case, an additional fixation system must be added. Titanium cages & screws are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications. Under no circumstances are the implants reusable.
MATERIALS: Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 and ISO 5832-3.
Function:
C-Curve was developed as an implant:
- To restore and maintain adequate interbody height.
- To stabilize the spine at one level & promote bony fusion.
5. Indication for Use
C-CURVE" is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The device is a stand-alone system when used C-Curve screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.
6. Substantial equivalence claimed to predicate devices
The C-Curve components are technologically similar to the already cleared predicates: the Titan Spine Endoskeleton TCS (K192018), the Atlas Spine HiJak SA (K192570), the Medtronic PEEK Prevail (K073285, K153373) and the ZIMMER SPINE Optio-C (K132894) in terms of intended use, material used, mechanical safety and performances.
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The table below compares the features and characteristics of the submitted C-Curve components to their predicate devices.
| Device | MEDICREA
INTERNATIONA
L
C-Curve | TITAN SPINE
Endoskeleton TCS | ATLAS SPINE
HIJAK SA | Medtronic
PEEK Prevail | ZIMMER SPINE
Optio-C |
|--------------------------------------|------------------------------------------------------|----------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------|
| 510(k)
number | To be
determined | K192018 | K192570 | K073285,
K153373 | K132894 |
| Intended
use | | | | | |
| Cervical via
anterior
approach | Yes | Yes | Yes | Yes | Yes |
| Components | | | | | |
| Device
component
s | Cage & 2
screws | Cage & 2 screws | Cage/plate &
2 screws | Cage & 2 screws | Cage/plate & 3
screws |
| Material | | | | | |
| | Cage: Ti-6Al-
4V ELI
Screws: Ti-
6Al-4V ELI | Cage: Ti-6Al-4V
ELI
Screws: Ti-6Al-4V
ELI | Cage: Ti-6Al-
4V ELI
Screws: Ti-
6Al-4V ELI | Cage: PEEK,
Tantalum &
Nitinol
Screws: Ti-6Al-
4V ELI | Cage: PEEK, Ti-
6Al-4V ELI
Screws: Ti-6Al-
4V ELI |
| Sterile
state | | | | | |
| | Provided
sterile | Provided sterile | Provided non
sterile | Provided sterile | Provided sterile |
7. Non-clinical Test Summary:
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
The C-Curve components are made from the same materials as its predicates and the manufacturing processes are similar to the ones of the predicates.
Mechanical testing
The tests performed on the C-Curve components (Static & Dynamix Axial Compression, Static & Dynamic Torsion, Static and Dynamic Compression Shear per ASTM F2077 , Subsidence per ASTM F2267 and Postero-anterior expulsion) indicate that the product is mechanically equivalent to its predicates.
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8. Conclusions
The subject C-Curve device demonstrated equivalent mechanical performance to the cited predicate device under the same test conditions.
The overall technology characteristics and mechanical performance data lead to the conclusion that the subject device is substantially equivalent to legally marketed predicate devices.