Benefix Interspinous Fixation System

K143631 · U&I Corporation · PEK · Sep 3, 2015 · Orthopedic

Device Facts

• Record ID: K143631
• Device Name: Benefix Interspinous Fixation System
• Applicant: U&I Corporation
• Product Code: PEK · Orthopedic
• Decision Date: Sep 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Benefix™ Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use.

Device Story

Posterior, non-pedicle spinal fixation system; consists of titanium alloy barrels, plates, and set screws. Provides immobilization and stabilization of spinous processes to support fusion. Used in non-cervical spine (T1-S1). Implanted by surgeons during spinal fusion procedures. Components assembled in various configurations to accommodate patient anatomy. Requires concurrent use of bone graft material. Not for stand-alone use.

Clinical Evidence

Bench testing only. Performed static compression bending, static torsion, compression bending fatigue, spike pull-off, and locking mechanism strength tests using modified ASTM F1717 standards.

Technological Characteristics

Titanium alloy (ASTM F136). Posterior, non-pedicle interspinous fixation system. Components: barrels, plates, set screws. Mechanical performance validated via modified ASTM F1717 testing. Single-use only.

Indications for Use

Indicated for patients requiring supplemental spinal fusion at a single level in the non-cervical spine (T1-S1) due to degenerative disc disease, trauma (fracture/dislocation), or tumor. Not for stand-alone use; must be used with bone graft material.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• X-Spine Systems AXLE™ Interspinous Fusion System (K130438)
• Medtronic CD Horizon SPIRE™ Stabilization System (K043053)
• Lanx Aspen™ Spinous Process System (K090252)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 3, 2015

U & I Corporation Mr. Young-Geun Kim Regulatory Affairs Specialist 20, Sandan-ro 76 beon-gil (Road) Uijeongbu-si, Gyeonggi-do Republic of Korea 480-859

Re: K143631

Trade/Device Name: Benefix™ Interspinous Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: August 17, 2015 Received: August 19, 2015

Dear Mr. 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 (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

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Page 2 - Mr. Young-Geun Kim

(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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins -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) K143631

Device Name Benefix™ Interspinous Fixation System

#### Indications for Use (Describe)

Benefix™ Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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# 510(k) Summary

| Manufacturer: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,<br>Korea, 480-859 |
|------------------------|-----------------------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation<br>20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,<br>Korea, 480-859 |
| Sponsor Contact: | Young-Geun Kim, Regulatory Affairs Specialist<br>[phone]<br>[e-mail] |
| Date Prepared: | Aug 17, 2015 |
| Trade Name: | BenefixTM Interspinous Fixation System |
| Device Classification: | Class II |
| Classification Name: | Spinal interlaminal fixation orthosis, per 21 CFR 888.3050 |
| Common Name: | Spinous Process Plate |
| Product Code: | PEK |
| Primary Predicate: | X-Spine Systems AXLETM Interspinous Fusion System<br>(K130438) |
| Additional Predicates: | Medtronic CD Horizon SPIRETM Stabilization System<br>(K043053)<br>Lanx AspenTM Spinous Process System (K090252) |

# Description of Device:

Benefix™ Interspinous Fixation System is manufactured by U&I Corporation. The System consists of various barrels, plates, and set screws. All implant components are made of titanium alloy in accordance with ASTM F136. Benefix™ Interspinous Fixation System is intended to provide immobilization and stabilization of the spinous processes to support fusion. The components can be assembled in a various configurations so that adaptations can be made to take into pathology and

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individual patient anatomy. All implants are intended for single use only and should not be reused under any circumstances.

# Indications for Use:

Benefix™ Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use.

### Substantial Equivalence:

Benefix™ Interspinous Fixation System is substantially equivalent to AXLE™ Interspinous Fusion System, CD Horizon SPIRE™ Stabilization System, Aspen™ Spinous Process System in design, material, mechanical performance, function and intended use.

Benefix™ Interspinous Fixation System has an extension design that is similar to AXLE ! Interspinous Fusion System. Benefix™ Interspinous Fixation System is relying on AXLE™ Interspinous Fusion, which has the same intended use as the Benefix™ Interspinous Fixation System, to support substantial equivalence with respect to technological characteristics.

# 1. Comparison of Technological Characteristics

The predicates and proposed device have the similar intended use and basic fundamental scientific technology and share the following similarities;

- The similar indications for use
- Similar design features
- Incorporate the same or similar materials
- The equivalent mechanical performance

Image /page/4/Picture/12 description: The image shows the logo for U&I Corporation. The logo features the letters "U&I" in a bold, sans-serif font, with the "i" having a red square above it. To the right of the letters, the word "CORPORATION" is written in a smaller, sans-serif font.

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# 2. Performance Testing

Benefix™ Interspinous Fixation System was tested in a non-clinical setting (bench testing), and the test results demonstrated that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices.

The following tests were performed:

- (1) Static compression bending test using a modified version of ASTM F1717
- (2) Static torsion test using a modified version of ASTM F1717.
- (3) Compression bending fatigue test using a modified version of ASTM F1717
- (4) Spike pull-off test
- (5) Locking mechanism strength test

# 3. Conclusion

The data and information provided in this submission support the conclusion that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices.

Image /page/5/Picture/10 description: The image shows the logo for U&I Corporation. The logo is black, except for a red square above the letter "i". The words "U&I" are in a stylized font, and the word "Corporation" is in a more standard font.