LAGUNA PEDICLE SCREW SYSTEM

K050060 · Allez Spine, LLC · MNI · May 4, 2005 · Orthopedic

Device Facts

• Record ID: K050060
• Device Name: LAGUNA PEDICLE SCREW SYSTEM
• Applicant: Allez Spine, LLC
• Product Code: MNI · Orthopedic
• Decision Date: May 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Laguna Spinal System is intended for posterior, non-cervical fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Device Story

Laguna Pedicle Screw System provides posterior, non-cervical spinal fixation; adjunct to fusion. System comprises titanium alloy rods and multi-axial screws (5mm-8mm diameters); screws accept 5.5mm rods. Surgeons configure constructs intraoperatively to stabilize thoracic, lumbar, or sacral segments. Device provides immobilization and correction of spinal deformities. Benefits include structural support for spinal fusion in patients with degenerative, traumatic, or neoplastic conditions.

Clinical Evidence

Bench testing only. Biomechanical tests performed; results equivalent to similar implants and sufficient for in vivo loading.

Technological Characteristics

Materials: Medical grade titanium alloy (ASTM F136, ISO 5832-3, or ISO 5832-2). Components: Multi-axial pedicle screws (5, 6, 7, 8mm diameters) and 5.5mm connecting rods. Configuration: Rigidly locked constructs tailored to individual cases. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for posterior, non-cervical spinal fixation in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or 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

• CD HORIZON Spinal System (K981676)

Submission Summary (Full Text)

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| MAY - 4 2005 | 510(k) Summary of Safety and Effectiveness [in accordance with SMDA of 1990, 21 CFR 807.92(c)] | K050060<br>1/1 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Contact: | Mr. Hartmut Loch, RAC<br>Regulatory Consultant & Official FDA<br>Correspondent for Allez Spine, LLC.<br>President, HHL Consulting Tel: [phone]<br>Fax: [phone]<br>c/o Allez Spine, LLC.<br>19772 Mac Arthur Blvd., Suite 150<br>Irvine, CA 92612 | |
| Trade name: | Allez Spine Laguna ^TM Pedicle Screw System | |
| Common name: | Spinal Fixation System | |
| Classification name: | Appliance, Fixation, Spinal Interlaminal - § 888.3050 (KWP)<br>Appliance, Fixation, Spinal Intervertebral - § 888.3060 (KWQ)<br>Orthosis, Spinal Pedicle Fixation - § 888.3070 (MNI)<br>Orthosis, SpondylolisthesisSpinal Fixation - § 888.3070 (MNH) | |
| | All Class II, Orthopedic Device Panel 87 | |
| Product Code: | KWP, KWQ, MNI & MNH | |
| Device Description and Characteristics: | The Laguna ^TM Pedicle Screw System is intended to help provide correction,<br>immobilization and stabilization of spinal segments as an adjunct to fusion<br>of the thoracic, lumbar and/or sacral space. | |
| | The Laguna Spinal System consists of a variety of rods and screws, which<br>can be rigidly locked into a variety of configurations, with each construct<br>being tailor made for the individual case. Multi axial implant screws are<br>supplied in 5mm, 6mm, 7mm and 8mm diameter sizes. All sizes are able to<br>receive 5.5mm connecting rods only. | |
| | The Laguna Spinal System implant components are fabricated from medical<br>grade titanium alloy described by such standards as ASTM F136 or ISO<br>5832-3 or 5832-2. | |
| Equivalence: | Allez Spine Laguna ^TM Pedicle Screw System is substantially equivalent to<br>the CD HORIZON Spinal System, which is manufactured and marketed by<br>Medtronic Sofamore Danek | |
| | K981676 S/E January 28, 1999 | |
| Indications: | The Laguna Spinal System is intended for posterior, non-cervical fixation for<br>the following conditions: degenerative disc disease (defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by history and<br>radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation);<br>spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor<br>pseudarthrosis; and/or failed previous fusion. | |
| Performance data: | Biomechanical tests have been performed. The test results were equivalent<br>to other similar implants and are sufficient for in vivo loading. | |

510(K) PREMARKET NOTIFICATION – Laguna™ Pedicle Screw System
January 10, 2005

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Image /page/1/Picture/12 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2005

Allez Spine, LLC C/o Mr. Hartmut Loch, RAC HHL Consulting, Inc. 2009 Freda Lane Cardiff, California 92007

Re: K050060

Trade/Device Name: LAGUNA™ Pedicle Screw System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: MNI, KWP, KWQ, MNH Dated: April 15, 2005 Received: April 18, 2005

Dear Mr. Loch:

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 11 your de roo 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 or any I 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 - Mr. Hartmut Loch, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This icticle with anow you to ogin maxing of substantial equivalence of your device to a legally prematicated 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 at (240) 276-__. Also, please note the regulation entitled, Connact the Oriece of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Stypt Rhodes

Miriam C. Provost, Ph.D. 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

510(k) Number (if known): K050060

Device Name:

LAGUNA™ Pedicle Screw System

Indications For Use:

The Laguna Spinal System is intended for posterior, non-The Laguna Spinal System in The following conditions: degenerative disc
cervical fixation for the following conditions: degenerative with cervical itxation for the following our of discogenic origin with disease (denned as back pain of creates by history and degeneration radiographic studies), spondylolisticss(i.e.scoliosis, kyphosis, kyphosis
dislocation); spinal stenosis; curvatures fi.e.sedios failod, previous dislocation), spinal stenoolo, surrature (and/or failed previous fusion.

Prescription Use (Part 21 CFR 801 Subpart D) AND/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)

Stpt Clurda

Division of General Restorative, and Neurological Devices

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510(k) Number