OPTIMA SPINAL SYSTEM

K051971 · U&I Corp. · KWQ · Aug 4, 2005 · Orthopedic

Device Facts

• Record ID: K051971
• Device Name: OPTIMA SPINAL SYSTEM
• Applicant: U&I Corp.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 4, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the OPTIMA™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). When used as an anterior screw fixation system, the OPTIMA™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis such as scoliosis, kyphosis, tumor, pseudoarthrosis, or revision of failed fusion attempts. In case of spinal deformities, OPTIMAT® may be used, with posterior hook.

Device Story

OPTIMA™ Spinal System is a top-loading, multi-component spinal fixation construct consisting of pedicle screws, connectors, and transverse (cross) linking mechanisms. Used by surgeons in clinical settings to stabilize spinal segments and promote fusion. Implants are fabricated from titanium alloy (Ti-6Al-4V ELI). Specialized surgical-grade stainless steel instruments are used for implantation and removal. The system provides mechanical immobilization of the thoracic, lumbar, and sacral spine. By stabilizing the affected segments, the device facilitates autogenous bone graft fusion, potentially reducing pain and correcting spinal deformities. The system is intended for removal after solid fusion is achieved.

Clinical Evidence

Bench testing only. Mechanical testing was performed in accordance with ASTM F1717-01 and ASTM F1798-97 to validate the structural integrity and performance of the spinal system.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136. Components: Pedicle screws, connectors, transverse linking mechanism. Mechanical testing standards: ASTM F1717-01 (static/dynamic testing of spinal implants) and ASTM F1798-97 (static/dynamic testing of spinal interbody fixation connectors).

Indications for Use

Indicated for skeletally mature patients requiring spinal stabilization/immobilization as an adjunct to fusion. Conditions include severe Spondylolisthesis (Grade 3-4), degenerative disc disease, fracture, dislocation, scoliosis, kyphosis, spinal tumor, spinal stenosis, and failed previous fusion (pseudarthrosis).

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Submission Summary (Full Text)

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# AUG 4 - 2005

### 510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

... !

| Submission Information: | | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Contact: | Betty Lim | Regulatory Affairs |
| Sponsor: | U&i Corporation<br>YongHyun-Dong 529-1, Euijungbu<br>Kyonggi-Do, Korea 480-050<br>Phone: [phone](ext. 254)<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Date Prepared: | July 18, 2005 | |
| Device Identification | | |
| Trade Name: | | OPTIMATM Spinal System |
| Common Name: | | Rod, hook, and screw spinal instrumentation |
| Classification Name: | | Spinal Pedical Fixation Orthosis (MNI) per 21 CFR § 888.3070 |
| | | Spondylolisthesis Spinal Fixation Orthosis (MNH) per 21 CFR § 888.3070 |
| | | Spinal Intervertebral Body Fixation Orthosis (KWQ) per 21 CFR § 888.3060 |
| | | |

Substantially Equivalent Predicate Legally Marketed Devices

The subject OPTIMA™ Spinal System is substantially equivalent in intended use, operating principle, materials, shelf life, packaging materials and process to:

Exhibit 5, Page 1 of 2

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### Device Description

The OPTIMA™ Spinal System is a top-loading multiple component, anterior / posterior The Of Think - Spinal System which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism.

The OPT/MA™ Spinal System will allow surgeons to build a spinal implant construct to The OPTIMA - Spinal System will anow Surgeone to band a band and on the are Stablice and promote opingle use and are fabricated from titanium alloy (Ti-6AI-4V ELI) supplied from storile, are single as and are sizes of these implants are available. that conforms to AOTM 1-100.
Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system

#### Indications for Use:

The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for The Of Think - postener Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in the treatment or sovery opendylanciscon by autogenous bone graft having implants Skeletally Thature patients rooming ne (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OPTIMA™ is intended to provide immobilization and stabilization of In 'addition', the 'O' Think in the intents as an adjunct to fusion in the treatment of Spirial segments in shelocally matast bilities of the thoracic, lumbar and the following doda and only of only objective evidence of neurological sacran spins. - dogGhoration, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system, the OPT/MA™ is indicated for patients Wilen used as an antenor solow which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, Spondylolisticslo, "Tractars," opinathrosis, or revision of failed fusion attempts.

### Statement of Technological Comparison:

Mechanical testing was carried out according to ASTM F1717-01 & ASTM F1798-97 to Mechanical testing was cat asseming The testing demonstrated substantially validate "the "OPTMA™, Spinal System in terms of intended use, operating principle, materials, shelf life, packaging materials and process.

Exhibit 5, Page 2 of 2

Page 2 + 2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, stylized with thick, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 - 2005

Ms. Betty Lim Regulatory Affairs U and I Corporation Youghyun Dong 529 1 Uijungbu, Kyunggi Do 480-050 Korea

Re: K051971

Trade/Device Name: OPTIMATM Spinal System Regulation Number: 21 CFR 888.3060, 21 CFR 888.3070 Regulation Name: Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWO, MNH, MNI, Dated: July 20, 2005 Received: July 21, 2005

Dear Ms. Lim:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Betty Lim

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Stipt Rurla

ark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS for USE STATEMENT

605197

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

Device Name: OPTIMA™ Spinal System.

Indications for Use: The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OPTIMA™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system, the OPTIMA™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis such as scoliosis, kyphosis, tumor, pseudoarthrosis, or revision of failed fusion attempts. In case of spinal deformities, OPTIMAT® may be used, with posterior hook.

× Prescription Use (Per 21 CFR 801 Subpart D)

OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stept Rlwdl

Division of General, Restorative, and Neurological Devices

510(k) Number_

Exhibit 2, Page 1 of 1

Page 1 of 1