EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM

K061978 · Ebi, L.P. · MNI · Aug 11, 2006 · Orthopedic

Device Facts

• Record ID: K061978
• Device Name: EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
• Applicant: Ebi, L.P.
• Product Code: MNI · Orthopedic
• Decision Date: Aug 11, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

Device Story

Array® Spinal System is a non-cervical spinal fixation device; functions as pedicle screw, posterior hook, sacral/iliac screw, or anterolateral fixation system. Used by surgeons in clinical settings to stabilize spine segments. Device components provide mechanical support to treat degenerative disc disease, trauma, deformity, tumor, stenosis, pseudarthrosis, and failed fusion. System is a line extension of previously cleared spinal fixation hardware; utilizes established mechanical principles for spinal stabilization.

Clinical Evidence

Bench testing only. Performance data comparatively evaluated the modified system against predicate devices to demonstrate that the system meets established mechanical design requirements.

Technological Characteristics

Non-cervical spinal fixation system including pedicle screws, hooks, and sacral/iliac screws. Mechanical performance validated against design specifications of predicate devices. No specific materials or software algorithms described.

Indications for Use

Indicated for skeletally mature patients (pedicle screw fixation) and general patients requiring non-cervical spinal fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), deformity (scoliosis, kyphosis, lordosis), tumor, stenosis, pseudarthrosis, and failed previous 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

• EBI® Array® Spinal System (formerly referred to as Top Loading MAS Spinal Fixation System)
• EBI® Webb Morley Spine System

Submission Summary (Full Text)

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K061978 (0 i of z)

### EBI, L.P.'s Line Extension to the Array® Spinal System

AUG 1 1 2006 SUBMITTER EBI, L.P. 100 Interpace Parkway ADDRESS: Parsippany, NJ 07054 [phone] PHONE: FAX: [phone] CONTACT PERSON: Jennifer P. Harakal July 12, 2006 DATE PREPARED: Array® Spinal System TRADE NAME: COMMON NAME: Spinal Fixation Device CLASSIFICATION NAME: Spondylolisthesis Spinal Fixation Device Spinal Intervertebral Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis -EBI® Array® Spinal System (formerly referred to as PREDICATE DEVICES: ·Top Loading MAS Spinal Fixation System') -EBI® Webb Morley Spine System

### INTENDED/INDICATIONS FOR USE:

The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and/or lordosis), tumor, stenosis, pscudarthrosis, and failed previous fusion.

### TECHNOLOGICAL CHARACTERISTICS:

#### Performance Testing

Performance data comparatively evaluating the modified system to its predicate devices demonstrate that the proposed system adequately meets the requirements established in design specifications for its mechanical performance. The design requirements were established based on those of the previously cleared predicate devices.

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Kobl978 (pg 2 of 2)

## Substantial Equivalence

The modified Array® Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and basic principles of operation. This premarket notification is being submitted to address a line extension princepts of operation was demonstrated by supporting performance data, these technological differences do not present any new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) of the United States. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the caduceus in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 1 2006

EBI, L.P. % Ms. Jennifer P. Harakal Regulatory Affairs Specialist 100 Interpace Pkwy P.O. Box 346 Parsippany, New Jersey 07054

Re: K061978

Trade/Device Name: Array® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: MNH, MNI, KWP, KWQ, NKB Dated: July 12, 2006 Received: July 13, 2006

Dear Ms. Harakal:

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 Eederal 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. This letter will allow you to

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## Page 2 - Ms. Jennifer P. Harakal

begin marketing your device as described in your Section 510(k) premarket notification. The FDA ocgli marketing your device 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 If you desire specific as no any liance 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 general information of your significance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buechner

Mark N. Melkerson 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

K OL 1977 510(k) Number (if known):

Device Name: Array® Spinal System

Indications for Use:

The Array Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Barbara Buckner

al. Restorative and Neurological De

**510(k) Number** K061978