Velofix™ TLIF Cage

K172419 · U&I Corporation · MAX · Dec 4, 2017 · Orthopedic

Device Facts

• Record ID: K172419
• Device Name: Velofix™ TLIF Cage
• Applicant: U&I Corporation
• Product Code: MAX · Orthopedic
• Decision Date: Dec 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.

Device Story

Velofix™ TLIF Cage is an intervertebral body fusion device designed for transforaminal lumbar interbody fusion (TLIF). The device features an open architecture for autogenous bone graft packing, pyramidal teeth for endplate engagement, and an articulating component that allows the cage to pivot into final position via an inserter instrument. It is implanted by a surgeon in a clinical setting. The device provides structural support to the intervertebral space to facilitate fusion. It is used in conjunction with supplemental internal spinal fixation. The device includes tantalum markers for radiographic visualization during and after implantation.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including static and dynamic compression testing, static and dynamic compression-shear testing, and subsidence testing conducted in accordance with ASTM F2077 and ASTM F2267 standards. Finite element analysis was also utilized to identify worst-case configurations for testing.

Technological Characteristics

Constructed of PEEK (ASTM F2026), Ti6Al4V ELI titanium alloy (ASTM F136) for the articulating component, and tantalum (ASTM F560) for radiographic markers. Instruments are stainless steel (ASTM F899). Features include pyramidal teeth, self-distracting nose, pivoting articulation mechanism, and open graft cavity. Available in various heights, widths, lengths, and lordotic angles (0°, 5°, 8°).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis at one or two contiguous lumbar levels (L2-S1) who have failed six months of non-operative treatment.

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

• Velofix™ Interbody Fusion System (K132926, K140864)
• PATRIOT® SPACER (K122097)
• Atlas Spine Pivoting System (K100743)
• AVS® Navigator PEEK Spacer (K151726)

Reference Devices

• TALON® TLIF Cage (K122518)
• Avenue® T TLIF Cage (K161173)
• DIO Medical IVA (TLIF) Cage (K162220)

Submission Summary (Full Text)

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December 4, 2017

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

U & I Corporation Jee-Ae Bang RA Assistant Manager 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, Gyeonggi-do, 11781 Korea

Re: K172419

Trade/Device Name: Velofix™ TLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 2, 2017 Received: November 3, 2017

Dear Jee-Ae Bang:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] 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) K172419

Device Name Velofix™ TLIF Cage

#### Indications for Use (Describe)

The Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 6. 510(k) Summary

| Manufacturer: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,<br>11781, Korea, |
|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,<br>11781, Korea, |
| Sponsor Contact: | Jee-Ae Bang, Regulatory Affairs Assistant Manager<br>[phone]<br>[e-mail] |
| Date Prepared: | November 02, 2017 |
| Device Name: | Trade Name: Velofix™ TLIF Cage |
| Classification Name: | Spinal Intervertebral Body Fusion Device, Lumbar<br>, per 21 CFR 888.3080 |
| Common Name: | Intervertebral Body Fusion Device, IBF Device |
| Product Code: | MAX |
| Primary Predicate Device: Velofix™ Interbody Fusion System (K132926, K140864) | |
| Secondary Predicate Devices: PATRIOT® SPACER (K122097)<br>Atlas Spine Pivoting System (K100743)<br>AVS® Navigator PEEK Spacer (K151726) | |

TALON® TLIF Cage (K122518) Avenue® T TLIF Cage (K161173) DIO Medical IVA (TLIF) Cage (K162220)

## Description of Device:

The Velofix™ TLIF Cage consists of implants available in various heights, width, length and angle with an open architecture to accept packing of auto bone graft material. The device is consisted of cage body, articulating component and radiographic markers. The articulating component is for attachment to the inserter instrument to allow the cage to pivot to the final positioning.

The Velofix™ TLIF Cage may be implanted a single device via a transforaminal approach and adopted to the anterior anatomy of the vertebral endplates.

The Velofix™ TLIF Cage is constructed of medical grade Polyetheretherketone (PEEK for ASTM F2026) with a titanium alloy for articulating component (Ti6Al4V ELI

Velofix™ TLIF Cage

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for ASTM F136), and tantalum radiographic markers for spinal applications(Tantalum for ASTM F560). The Velofix™ TLIF Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.

## Indications For Use:

The Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.

#### Substantial Equivalence:

Velofix™ TLIF Cage is substantially equivalent to Velofix™ Interbody Fusion System (K132926, K140864), PATRIOT® SPACER (K122097), Atlas Spine Pivoting System (K100743), AVS® Navigator PEEK Spacer (K151726), TALON® TLIF Cage (K122518), Avenue® T TLIF Cage (K161173) and DIO Medical IVA (TLIF) Cage (K162220) in design, material, mechanical performance, function and intended use.

The mechanical performance of the additional size of Velofix™ TLIF Cage met the acceptance criteria which have been established from the predicate devices.

- 1. Comparison Technological Characteristics
The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities;

- The similar indications for use
- Similar design features
- . Pyramidal teeth on superior and inferior surfaces.
- . Self-distracting nose which allows for insertion.
- . Articulation mechanism which allows the cage to pivot to final positioning.
- . Large graft cavity for bone graft packing to help aid in the fusion process.
- Anterior and posterior side holes. .
- . Tantalum Markers which produce radiographic visualization during implant insertion and final position.
- Various lordosis angles(0°, 5°, 8°). .

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- Incorporate the same or similar materials
- The equivalent mechanical performance

## 2. Performance Testing

The Velofix™ TLIF Cage was tested in a non clinical setting (bench testing). All tests met all acceptance criteria and that verifies performance of the Velofix™ TLIF Cage is substantially equivalent to predicate devices. The acceptance criteria for performance testing were developed using the data of the primary predicate, Velofix 10 Interbody Fusion System (K132926, K140864).

The following tests were performed:

- (1) Static compression test according to ASTM F2077
- (2) Dynamic compression test according to ASTM F2077
- (3) Static compression-shear test according to ASTM F2077
- (4) Dynamic compression-shear test according to ASTM F2077
- (5) Subsidence test according to ASTM F2267

Additionally, the finite element analysis was performed to aid in the selection of the worst case implants.

## 3. Conclusion

The data and information provided in this submission support the conclusion that the Velofix™ TLIF Cage is substantially equivalent to predicate devices with respect to indications for use and technological characteristics.