FIX-C 3D Ti ACIF System

K243915 · Jeil Medical Corporation · ODP · Feb 18, 2025 · Orthopedic

Device Facts

• Record ID: K243915
• Device Name: FIX-C 3D Ti ACIF System
• Applicant: Jeil Medical Corporation
• Product Code: ODP · Orthopedic
• Decision Date: Feb 18, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

FIX-C 3D Ti ACIF System consists of 3D-printed porous titanium spinal cages; used in anterior cervical interbody fusion (ACIF) procedures to stabilize spinal segments, restore intervertebral height, and facilitate fusion. Cages are implanted by surgeons in an OR setting; used in conjunction with supplemental anterior plate fixation systems. Hollow geometry allows packing with autogenous or allogeneic bone graft to promote bone growth. Device is provided non-sterile and requires sterilization by the user. Benefits include spinal stabilization and pain relief for patients with cervical disc degeneration or instability.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including static and dynamic axial compression, compression-shear, and torsion tests per ASTM F2077, and subsidence testing per ASTM F2267.

Technological Characteristics

Material: Ti-6Al-4V ELI (ASTM F3001). Manufacturing: Additive manufacturing (Selective Laser Melting). Form factor: 3D-printed porous titanium spinal cages with hollow geometry for bone graft. Sterilization: Non-sterile, requires ISO 17665-1 sterilization. Connectivity: None.

Indications for Use

Indicated for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability (confirmed by imaging) resulting in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1. Requires at least six weeks of prior nonoperative treatment. Used with supplemental cervical fixation and autogenous/allogeneic bone graft.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Peridot-PT Anterior Cervical Intervertebral body fusion System (K233839)
• PYXIS 3D Titanium Cervical Cage System (K241738)
• FIX-C PEEK Anterior Cervical Interbody System (K212266)

Submission Summary (Full Text)

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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 [phone] 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)

K243915

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,<br>Guro-gu Seoul 08378 Korea, South | | |
| Applicant Contact Telephone | | [phone] | | |
| Applicant Contact | | Ms. Jinwoo Kim | | |
| Applicant Contact Email | | [e-mail] | | |
| 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<br>intervertebral height, and facilitate interbody fusion in the cervical. The spinal cages are used in the anterior cervical interbody fusion<br>(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,

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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)