OPTIMA, SPINAL SYSTEM

K024096 · U&I Corp., America · MNI · Mar 12, 2003 · Orthopedic

Device Facts

• Record ID: K024096
• Device Name: OPTIMA, SPINAL SYSTEM
• Applicant: U&I Corp., America
• Product Code: MNI · Orthopedic
• Decision Date: Mar 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• 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, spinal deformities such as scoliosis, kyphosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

Device Story

OPTIMA™ Spinal System is top-loading, multi-component anterior/posterior spinal fixation system; includes pedicle screws, rods, set screws, connectors, and transverse linking mechanism. Used by surgeons in clinical settings to build spinal implant constructs for stabilization and fusion. Components fabricated from titanium alloy (Ti-6Al-4V ELI); specialized surgical grade stainless steel instruments used for application/removal. System provides mechanical immobilization of spinal segments; supports fusion process in patients with spinal deformities or instabilities. Benefits include structural stabilization of spine to promote healing and fusion.

Clinical Evidence

Bench testing only. Testing conducted in accordance with ASTM F1717 to demonstrate mechanical equivalence to predicate devices.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F 136. Components: Pedicle screws, rods, set screws, connectors, transverse linking mechanism. Design: Top-loading, anterior/posterior spinal fixation system. Energy source: None (mechanical). Sterilization: Supplied non-sterile. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients requiring spinal stabilization/fusion. Posterior system: severe Spondylolisthesis (Grade 3-4) at L5-S1; acute/chronic instabilities or deformities (degenerative Spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, tumor, pseudarthrosis) of thoracic, lumbar, and sacral spine. Anterior system: degenerative disc disease, Spondylolisthesis, fracture, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or revision of failed fusion.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• OPTIMA™, Spinal System (K020279)
• Micron Precision Engineering, AMT Spinal System (K002059)
• Stryker® Spine, Xia™ Spinal System (K001319)

Submission Summary (Full Text)

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## 510(k) SUMMARY

@24096
page 1 of 2

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

Submission Information:

MAR 1 2 2003

| Contact: | Patrick Moore<br>Manager, Quality Assurance |
|----------|-----------------------------------------------------------------------------------------------------------------|
| Sponsor: | U&i Corporation, America<br>6132 South 380 West<br>Murray, UT 84107<br>Phone: [phone]<br>Fax: [phone] |

December 4, 2002 Date Prepared:

Device Identification:

| Trade Name: | OPTIMA ^TM , Spinal System |
|----------------------|-----------------------------------------------------------------------------|
| Common Name: | Pedical Screw Spinal Fixation System |
| Classification Name: | Spinal Pedical Screw (MNI) per 21 CFR § 888.3070 |
| | Spondylolisthesis Spinal Fixation Device System (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 function, design, composition, labeling, and intended use to:

OPTIMA™, Spinal System MNH, MNI, KWQ - (K020279). Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) Stryker® Spine, Xia™ Spinal System -- MNH, MNI, KWQ -- (K001319)

The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the above listed predicate devices.

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### Device Description:

024096
page 2 of 2

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

The OPTIMA™ system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The OPTIMA™ implant system components are supplied non-sterile are single use and are fabricated from titanium allov (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. 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 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 seqments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, Jumbar and sacral spine: degenerative Spondy|olisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor 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, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts,

#### Statement of Technological Comparison:

The subject spinal implant system is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles,

#### Performance Data:

Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping abstract shapes, possibly representing human figures or birds in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2003

Mr. Patrick Moore Manager, Quality Assurance U&I Corporation, America 6132 South 380 West Murray, Utah 84107

Re: K024096 Trade Name: OPTIMA™, Spinal System Regulation Number: 21 CFR 888.3070, 888.3060 Regulation Name: Pedicle screw spinal system, Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWQ Dated: December 4, 2002 Received: December 12, 2002

Dear Mr. Moore:

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

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# Page 2 - Mr. Patrick Moore

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. 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/dsma/dsmamain.html.

Sincerely vours,

R Mark N. Milkerso

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### SECTION II

024096

#### INDICATIONS for USE STATEMENT

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, spinal deformities such as scollosis, kyphosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------|
| <div> <div style="text-align: center;">(Division Sign-Off)</div> <div>Division of General, Restorative</div> <div>and Neurological Devices</div> </div> | | |
| 510(k) Number | K024096 | |
| Prescription Use | OR Over-the-Counter Use<br>(Optional Format 1-2-96) | (Per 21 CFR 801.109) |

પદ્ધા OPTIMA™ Device Premarket Notification

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