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 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.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 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.

Device 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 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.

AI/ML Overview

The provided document does not describe an AI/ML powered device. Instead, it concerns a medical device called the "Malibu Spinal System," which is a traditional orthopedic implant for spinal fusion.

Therefore, the requested information elements such as "acceptance criteria and the study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for the training set was established" are not applicable to this document. These items are specific to the evaluation of AI/ML diagnostic or assistive devices, not mechanical implants.

The document focuses on demonstrating substantial equivalence of the Malibu Spinal System to predicate devices already on the market, primarily through comparison of:

Intended Use
Indications for Use
Design
Materials
Sterilization
Mechanical Strength

The acceptance criteria for such a device are typically met by demonstrating that its materials, design, and mechanical performance are equivalent to, or better than, legally marketed predicate devices, and that it is safe and effective for its intended use. The "study" mentioned for mechanical strength would be mechanical testing (e.g., fatigue, static strength) to ensure the device can withstand physiological loads, not clinical studies in the AI/ML context. The document explicitly states "Mechanical Strength: See test results," indicating that such tests were performed.

Summary

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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.Contact: Diana Smith2302 La Mirada DriveVista, CA 92081-7862Phone: 760-727-8399 Fax: 760-727-8809
Company Registration Number:	2032593
Submission Correspondent:	SeaSpine, Inc.Contact: Diana Smith, Manager ofRegulatory Affairs and Quality Assurance2302 La Mirada DriveVista, CA 92081-7862Phone: 760-727-8399 Fax: 760-727-8809
Date Summary Prepared:	July 12, 2005
Classification Name:	Pedicle Screw Spinal SystemMNH (Class II) - 888.3070(b)(1)MNI (Class II) - 888.3070(b)(1)NKB (Class III) - 888.3070(b)(2)Spinal Interlaminal Fixation OrthosisKWP (Class II) - 888.3050
Common/Usual Name:	Polyaxial Screws, Polyaxial ReductionScrews, Locking Caps, Components, andInstruments
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).

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

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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.

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:

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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.

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	SynthesClick'XMonoaxialSystem	Moss MiamiSpinal System	SeaSpine UCRSpinal System	SubstantiallyEquivalent
Intended Use	The intended use of theMalibu Spinal System is asa temporary or permanentposterior, non-cervicalimplant to correct spinaldisorders and providestabilization of the spine topermit the biologicalprocess of spinal fusions tooccur.	Similar	Similar	Similar	Yes
Indications forUse	Degenerative disc disease(DDD) as defined by backpain of discogenic originwith degeneration of thedisc confirmed by patienthistory and radiographicstudies.spondylolisthesis,trauma (i.e., fracture ordislocation),spinal stenosis,deformities or curvatures(i.e., scoliosis, kyphosis,and/or lordosis),tumor,pseudarthosis, and/orfailed previous fusion.	Similar	Similar	Similar	Yes
Design	Iliac monoaxial screws,monoaxial screws, lockingcaps, rods, hooks, andcomponents	Similar	Similar	Similar	Yes
IliacMonoaxialScrews	See prints	Similar	Similar	Similar	Yes
MonoaxialScrews	See prints	Similar	Similar	Similar	Yes
Caps	See prints	Similar	Similar	Similar	Yes
LaminarHooks	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 ofSterilization	High-temperature steam	Similar	Similar	Similar	Yes
MechanicalStrength	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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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.

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(Part 21 CFR 801 Subpart D)	X
-------------------------------------------------	---

AND/OR

Over-The-Counter-Use(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

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
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.(b)
Classification. Class II.