(60 days)
Not Found
No
The summary describes a 3D-printed titanium spinal cage and its intended use and mechanical testing. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is a medical implant intended to treat specific medical conditions (cervical disc degeneration, spinal instability, radiculopathy, myelopathy, pain) by stabilizing the spine and facilitating fusion, which are therapeutic actions.
No
This device is an implantable medical device used for spinal fusion, not for diagnosing conditions. Its function is to stabilize the spine and facilitate fusion, not to identify or characterize diseases.
No
The device description explicitly states that the device comprises "3D-printed porous titanium spinal cages," which are physical hardware components intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The FIX-C 3D Ti ACIF System is a physical implant (spinal cage) designed to be surgically placed in the cervical spine. It is a medical device used in vivo (within the body) to provide structural support and facilitate bone fusion.
- Intended Use: The intended use clearly describes a surgical procedure for treating cervical disc degeneration and instability by implanting the device. It does not involve testing samples from the body.
The information provided describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The FIX-C 3D Ti ACIF System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1.
The FIX-C 3D Ti ACIF System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The FIX-C 3D Ti ACIF System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The FIX-C 3D Ti ACIF System comprises of 3D-printed porous titanium spinal cages intended to stabilize the spinal segment, restore intervertebral height, and facilitate interbody fusion in the cervical. The spinal cages are used in the anterior cervical interbody fusion (ACIF) procedures. The devices are intended to be used with supplemental spinal fixation (e.g., using anterior plate system).
The spinal cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures. The hollow geometry of the spinal cages allows them to be packed with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft.
The FIX-C 3D Ti ACF System is manufactured in a pre-designated standard size, not patient-matched. The spinal cages are available in various sizes, footprints, heights, and angles.
The FIX-C 3D Ti ACIF System is provided non-sterile. The devices must be sterilized prior to use per ISO 17665-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
cervical spine, C2-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)
Bench tests were conducted to demonstrate substantial equivalence to the tests were conducted according to the following standards:
- ASTM F2077, Standard Test Methods for Intervertebral Body Fusion Devices
- Static axial compression test
- Static compression-shear test
- Static torsion test
- Dynamic axial compression test
- Dynamic compression-shear test
- Dynamic torsion test
- ASTM F2267, Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- Subsidence test
All test results were higher than the acceptance criteria from the refore, substantially equivalent mechanical performance with the predicate device has been demonstrated. Clinical data is not applicable.
- Subsidence test
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.
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
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February 18, 2025
Jeil Medical Corporation Jinwoo Kim RA Specialist 702-703-704-705-706-707-804-805-807-812-815-ho, 55, Digital-ro 34-gil, Guro-gu Seoul, South Korea
Re: K243915
Trade/Device Name: FIX-C 3D Ti ACIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 20, 2024 Received: December 20, 2024
Dear Jinwoo Kim:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Brent Showalter -S
Brent 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
Submission Number (if known)
Device Name
FIX-C 3D Ti ACIF System
Indications for Use (Describe)
The FIX-C 3D Ti ACIF System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1.
The FIX-C 3D Ti ACIF System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The FIX-C 3D Ti ACIF System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
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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| 510(k) #: K243915 | 510(k) Summary | Prepared on: 2024-12-20 | ||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Jeil Medical Corporation | |||
| Applicant Address | 702-703-704-705-706-707-804-805-807-812-815-ho, 55, Digital-ro 34-gil, | |||
| Guro-gu Seoul 08378 Korea, South | ||||
| Applicant Contact Telephone | +82 2 850 3934 | |||
| Applicant Contact | Ms. Jinwoo Kim | |||
| Applicant Contact Email | jinwookim@jeilmed.co.kr | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | FIX-C 3D Ti ACIF System | |||
| Common Name | Intervertebral body fusion device | |||
| Classification Name | Intervertebral Fusion Device With Bone Graft, Cervical | |||
| Regulation Number | 888.3080 | |||
| Product Code(s) | ODP | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System | ODP | ||
| K241738 | PYXIS 3D Titanium Cervical Cage System | ODP | ||
| K212266 | FIX-C PEEK Anterior Cervical Interbody System | ODP | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| The FIX-C 3D Ti ACIF System comprises of 3D-printed porous titanium spinal cages intended to stabilize the spinal segment, restore | ||||
| intervertebral height, and facilitate interbody fusion in the cervical. The spinal cages are used in the anterior cervical interbody fusion | ||||
| (ACIF) procedures. The devices are intended to be used with supplemental spinal fixation (e.g., using anterior plate system). |
The spinal cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures. The hollow geometry of the spinal cages allows them to be packed with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft.
The FIX-C 3D Ti ACF System is manufactured in a pre-designated standard size, not patient-matched. The spinal cages are available in various sizes, footprints, heights, and angles.
The FIX-C 3D Ti ACIF System is provided non-sterile. The devices must be sterilized prior to use per ISO 17665-1.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The FIX-C 3D Ti ACIF System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy,
5
myelopathy, and/or pain at one or multiple contiguous levels from C2-T1.
The FIX-C 3D Ti ACIF System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The FIX-C 3D Ti ACIF System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Indications for Use Comparison
There are no differences of Indications for use between the subject device and the predicate device (K233839),
Technological Comparison
Based on the technological feature comparison, the subject device was found to have no significant differences between the subject device and the predicate device that would adversely affect the use of the product, and it is substantially equivalent to the predicate device in technological characteristics.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The subject device and predicate device are 3D-printed porous titanium spinal cages are used in the anterior cervical interbody fusion (ACIF) procedures. Detailed design/dimension would not be the same, but equivalent.
Bench tests were conducted to demonstrate substantial equivalence to the tests were conducted according to the following standards:
- · ASTM F2077, Standard Test Methods for Intervertebral Body Fusion Devices
- Static axial compression test
- Static compression-shear test
- Static torsion test
- Dynamic axial compression test
- Dynamic compression-shear test
- Dynamic torsion test
• ASTM F2267, Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- Subsidence test
Clinical data is not applicable.
Bench tests were conducted for the subject device according to ASTM F2267. All test results were higher than the acceptance criteria from the refore, substantially equivalent mechanical performance with the predicate device has been demonstrated.
Based on the indications for use, technological characteristics, bench testing, and comparison with the subject device has demonstrated substantial equivalence for its intended use.
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)