MALIBU SPINAL SYSTEM

K051942 · Seaspine, Inc. · KWP · Jul 27, 2005 · Orthopedic

Device Facts

• Record ID: K051942
• Device Name: MALIBU SPINAL SYSTEM
• Applicant: Seaspine, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jul 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Malibu Spinal System polyaxial screws, polyaxial reduction screws, locking caps, and components, is substantially equivalent to the intended use of the predicate devices. The intended use of the Malibu Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5.

Device Story

Malibu Spinal System is a posterior, non-cervical spinal fixation implant system. Components include polyaxial screws, polyaxial reduction screws, locking caps, rods, and hooks. System provides immobilization and stabilization of spinal segments to facilitate fusion. Used in thoracic, lumbar, and sacral spine. Implants are titanium alloy; some components include cobalt alloy. Instruments are stainless steel, titanium alloy, aluminum, and Radel. Supplied non-sterile; requires steam sterilization by hospital staff. Designed for use by surgeons in clinical settings. Compatible with SeaSpine UCR Spinal System components. Provides mechanical stabilization to treat spinal instabilities or deformities.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium alloy implants with cobalt alloy components. Instruments made of stainless steel, titanium alloy, aluminum, and Radel. Polyaxial and monoaxial screw designs. Non-sterile, steam-sterilized. Standalone system compatible with UCR Spinal System.

Indications for Use

Indicated for skeletally mature patients requiring spinal stabilization/immobilization as an adjunct to fusion for: degenerative disc disease (discogenic back pain), spondylolisthesis (including severe Grades 3-4 at L5-S1), trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), spinal tumor, pseudoarthrosis, and failed previous fusion. Hook system limited to T1-L5.

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

• Synthes Click'X Monoaxial Screw System (K031175)
• Moss Miami Spinal System (K002607 and K992168)
• SeaSpine UCR Spinal System (K993503, K021623, K031381, K032739/S1 and K043232)

Submission Summary (Full Text)

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KOS 1942

# JUL 2 7 2005

CONFIDENTIAL

### Malibu Spinal System

# 510(K) SUMMARY

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.

| Submitter Information: | SeaSpine, Inc.<br>Contact: Diana Smith<br>2302 La Mirada Drive<br>Vista, CA 92081-7862<br>Phone: [phone] Fax: [phone] |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | SeaSpine, Inc.<br>Contact: Diana Smith, Manager of<br>Regulatory Affairs and Quality Assurance<br>2302 La Mirada Drive<br>Vista, CA 92081-7862<br>Phone: [phone] Fax: [phone] |
| Date Summary Prepared: | July 12, 2005 |
| Classification Name: | Pedicle Screw Spinal System<br>MNH (Class II) - 888.3070(b)(1)<br>MNI (Class II) - 888.3070(b)(1)<br>NKB (Class III) - 888.3070(b)(2)<br>Spinal Interlaminal Fixation Orthosis<br>KWP (Class II) - 888.3050 |
| Common/Usual Name: | Polyaxial Screws, Polyaxial Reduction<br>Screws, Locking Caps, Components, and<br>Instruments |
| Device Trade Name: | Malibu Spinal System |

The devices used for comparison in this summary are Synthes Spine Company's Synthes Click'X Monoaxial Screw System (K031175), DePuy Acromed's Moss Miami Spinal System (K002607 and K992168) and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/S1 and K043232).

1. Intended Use: (The statements of intended use are identical.)

The intended use of the Malibu Spinal System polyaxial screws, polyaxial reduction screws, locking caps, and components, is substantially equivalent to the intended use of the predicate devices. The intended use of the Malibu Spinal System is as a

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#### Malibu Spinal System

temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:

- degencrative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally . mature patients receiving fusions 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 (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis, .
- trauma (i.e., fracture or dislocation), .
- spinal stenosis. .
- . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- spinal tumor, .
- pseudoarthrosis, and/or ◆
- failed previous fusion. ●

The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to 71-L5 and are as follows:

- . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- . spondylolisthesis
- trauma (i.e., fracture or dislocation), ●
- spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
- ◆ tumor,
- pseudarthosis, and/or ●
- failed previous fusion. .

#### 2. Description:

The Malibu Spinal System includes titanium alloy polyaxial reduction screws with a cobalt alloy component. Both screw types will be offered in numerous diameters and lengths. The screw is comprised of a screw body and housing

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#### CONFIDENTIAL

#### Malibu Spinal System

assembly. Both screws are designed to be part of the Malibu system, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will also include locking caps in two different sizes. These items are designed to be part of the stand alone Malibu Spinal System, but are compatible with and will work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will offer a wide variety of instruments that range from modular taps to angled in-situ benders. These various instruments will be made primarily from various grades of stainless steel with a few components made from titanium alloy, aluminum, and Radel. These items are supplied "NON-STERILE" and must be sterilized prior to use.

#### 3. Technological Characteristics:

The polyaxial screws, polyaxial reduction screws, locking caps, components, and instruments in this notification are components of a new stand alone system called Malibu Spinal System, but are designed to be compatible with and work in conjunction with the components in the current SeaSpine UCR Spinal System. The devices in this submission have substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.

#### 4. Comparison Analysis:

The overall designs of the Malibu Spinal System polyaxial screws, polyaxial reduction screws, locking caps, and components are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the Malibu Spinal System polyaxial screws, polyaxial reduction screws, locking caps, and components to the predicate devices.

> 21 C

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# KOS નિનડ

# CONFIDENTIAL

# Malibu Spinal System

| Feature | Malibu Spinal System | Synthes<br>Click'X<br>Monoaxial<br>System | Moss Miami<br>Spinal System | SeaSpine UCR<br>Spinal System | Substantially<br>Equivalent |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------|-------------------------------|-----------------------------|
| Intended Use | The intended use of the<br>Malibu Spinal System is as<br>a temporary or permanent<br>posterior, non-cervical<br>implant to correct spinal<br>disorders and provide<br>stabilization of the spine to<br>permit the biological<br>process of spinal fusions to<br>occur. | Similar | Similar | Similar | Yes |
| Indications for<br>Use | Degenerative disc disease<br>(DDD) as defined by back<br>pain of discogenic origin<br>with degeneration of the<br>disc confirmed by patient<br>history and radiographic<br>studies.<br>spondylolisthesis,<br>trauma (i.e., fracture or<br>dislocation),<br>spinal stenosis,<br>deformities or curvatures<br>(i.e., scoliosis, kyphosis,<br>and/or lordosis),<br>tumor,<br>pseudarthosis, and/or<br>failed previous fusion. | Similar | Similar | Similar | Yes |
| Design | Iliac monoaxial screws,<br>monoaxial screws, locking<br>caps, rods, hooks, and<br>components | Similar | Similar | Similar | Yes |
| Iliac<br>Monoaxial<br>Screws | See prints | Similar | Similar | Similar | Yes |
| Monoaxial<br>Screws | See prints | Similar | Similar | Similar | Yes |
| Caps | See prints | Similar | Similar | Similar | Yes |
| Laminar<br>Hooks | See prints | Similar | Similar | Similar | Yes |
| Pedicle Hooks | See prints | Similar | Similar | Similar | Yes |
| Offset Hooks | See prints | Similar | Similar | Similar | Yes |
| Material | Titanium alloy | Similar | Similar | Similar | Yes |
| Sterile | Non-sterile | Similar | Similar | Similar | Yes |
| Method of<br>Sterilization | High-temperature steam | Similar | Similar | Similar | Yes |
| Mechanical<br>Strength | See test results | Similar | Similar | Similar | Yes |

| | | Table 1: Summary of Design Comparison | | | | |
|--|--|---------------------------------------|--|--|--|--|
|--|--|---------------------------------------|--|--|--|--|

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." is written around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 7 2005

Ms. Diana Smith Manager of Regulatory Affairs and Quality Assurance SeaSpine, Inc. 2302 La Miranda Drive Vista, California 92801

Re: K051942

Trade/Device Name: Malibu Spinal System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: III Product Code: KWP, MNH, MNI, NKB Dated: July 12, 2005 Received: July 18, 2005

Dear Ms. Smith:

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. Diana Smith

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,

Stupt Curler

Mark 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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#### Malibu Spinal System

Indications for Use Statement

KOS 1442

510(k) Number (if known):

Device Name: Malibu Spinal System

Indications for Use:

The intended use of the Malibu Spinal System, polyaxial screws, polyaxial reduction screws, locking caps, and components, is substantially equivalent to the intended use of the predicate device. The intended use of the Malibu Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:

- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally . mature patients receiving fusions 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 (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis. ●
- trauma (i.c., fracture or dislocation), ●
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
- . spinal tumor,
- pscudoarthrosis, and/or .
- failed previous fusion.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

| Over-The-Counter-Use<br>(21 CFR 807 Subpart C) | |
|------------------------------------------------|--|
|------------------------------------------------|--|

(Division Sign-Off) DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).Division of General, Restoralities of CDRH, Office of Device Evaluation (ODE) and Neurological Devices

KOS1942 510(k) Number_

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## Malibu Spinal System

## Indications for Use Statement continued

The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis .
- trauma (i.e., fracture or dislocation), .
- spinal stenosis, ◆
- . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- . tumor,
- ◆ pseudarthosis, and/or
- failed previous fusion. .

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter-Use | |
| (21 CFR 807 Subpart C) | |

(Division Sign-Off)

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

Division of General, Restorative. Concurrence of CDRH, Office of Device Evaluation (ODE)

and Neurological Devices

**510(k) Number** K051942

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