REXIOUS HOOK FIXATION SYSTEMS

K113324 · Dio Medical Co., Ltd. · KWP · Mar 28, 2012 · Orthopedic

Device Facts

• Record ID: K113324
• Device Name: REXIOUS HOOK FIXATION SYSTEMS
• Applicant: Dio Medical Co., Ltd.
• Product Code: KWP · Orthopedic
• Decision Date: Mar 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rexious Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for 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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Rexious Hook System can be used in conjunction with the Rexious Spinal Fixation System.

Device Story

Top-loading posterior spinal fixation system; consists of hooks, rods, set screws, connectors, and transverse link system. Used in posterior plane for unilateral fixation. Design allows sagittal and coronal plane adjustment for optimal anatomic placement. Used by surgeons in clinical settings to stabilize the spine. Provides mechanical support to facilitate fusion or stabilization in patients with spinal pathologies. Can be used in conjunction with Rexious Spinal Fixation System.

Clinical Evidence

Bench testing only. Performance characterized via ASTM F1717 testing, including static compression bending, static tension, static torsion, and dynamic compression tests.

Technological Characteristics

Posterior spinal fixation system; components fabricated from titanium alloy (Ti6Al4V ELI) conforming to ASTM F 136. Features top-loading design with hooks, rods, set screws, connectors, and transverse link system. Allows sagittal and coronal plane adjustment. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for patients requiring posterior, noncervical, nonpedicle spinal fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis/lordosis), tumor, pseudoarthrosis, or failed previous fusion.

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

• U&I America, Spinal Hook System™ (K031595)

Submission Summary (Full Text)

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MAR 2 8 2012

K11 3324
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## 510(k) Summary

As specified under 21 CFR 807.92,

### Submitter:

DIO Medical Co., Ltd. Sung-Hee Lee 103~105 Megacenter, SK Technopark 190-1 Sangdaewon-dong, Jungwon-guSungnam-si Kyunggi-do, South Korea Phone: [phone] Fax: [phone]

# Official Correspondent: Kodent Inc. April Lee

325 N. Puente St. Unit B Santa Fe Springs, CA 90670 Email; [e-mail] Phone: [phone] Fax: [phone]

#### Device Information

Trade Name: RexiousHook System Classification Name: Spinal Interlaminal Fixation Orthosis Product Code: KWP Regulation Number: 888.3050 Date Prepared: 3/21/2012

#### General Description

The Rexious Hook System is a top-loading posterior spinal fixation system which consists of hooks, rods, set screws, connectors and a transverse link system. The Rexious Hook System implant components are fabricated from titanium alloy (Ti6A14V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.

The Rexious Hook System can be used in the posterior plane providing unilateral modes of fixation.

The Rexious Hook System design allows adjustment in both the sagittal and coronal planes permitting hook placement according to the best possible anatomic location and orientation.

#### Indication for Use

r

The Rexious Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for 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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Rexious Hook System can be used in conjunction with the Rexious Spinal Fixation System.

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K113324
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#### Materials:

The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO Standards.

### Performance Data:

Performance tests per ASTM F1717 such as static compression bending, static tension, static torsion, and dynamic compression tests were submitted to characterize the subject Rexious Hook System components addressed in this notification.

### Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

*U&I America, Spinal Hook System™ (K031595)

#### Comparison to Predicate Devices:

The Substantial equivalence of this device is based on equivalence in intended use, material, designs, and operational principles to the predicate device, U&I America, Spinal Hook System™ (K031595).

#### Conclusion

Both the performance testing and comparison to predicate device demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device.

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

DIO Medical Co., Ltd. % Kodent Incorporated Ms. April Lee 325 North Puente Street, Unit B Brea, California 92821

MAR 2 8 2012

Re: K113324

Trade/Device Name: Rexious Hook System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: March 22, 2012 Received: March 26, 2012

Dear Ms. Lee:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. April Lee

forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For
Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indication for Use

K113324

### 510(K) Number (if known):

Device Name: Rexious Hook System

### Indication for Use:

The Rexious Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for 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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Rexious Hook System can be used in conjunction with the Rexious Spinal Fixation System.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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(Diysion Sign-Ori) Difision of Surgical Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________