LAGUNA SIZE 8 PEDICLE SCREW

K072678 · Allez Spine, LLC · NKB · Jul 2, 2008 · Orthopedic

Device Facts

• Record ID: K072678
• Device Name: LAGUNA SIZE 8 PEDICLE SCREW
• Applicant: Allez Spine, LLC
• Product Code: NKB · Orthopedic
• Decision Date: Jul 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LAGUNA™ Spinal System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical pedicle 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™ Size 8 Pedicle Screws are spinal fixation implants used to provide correction, immobilization, and stabilization of spinal segments. Used as an adjunct to fusion in the thoracic, lumbar, and sacral spine. Components include rods and polyaxial pedicle screws, which are locked into custom configurations for individual patient anatomy. Operated by surgeons in a clinical/surgical setting. Benefits include spinal stabilization and support for fusion. Device is a mechanical implant; no software or algorithm involved.

Clinical Evidence

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

Technological Characteristics

Fabricated from medical grade titanium alloy (ASTM F136, ISO 5832-3, or ISO 5832-2). Polyaxial pedicle screw design. Available in eleven sizes (30 mm to 100 mm). Mechanical fixation system.

Indications for Use

Indicated for patients requiring posterior, non-cervical pedicle fixation as an adjunct to fusion for 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

• LAGUNA™ Polyaxial Pedicle Screw System (K050060)

Submission Summary (Full Text)

{0}------------------------------------------------

Page 1 of 1

ALLëZ
SPINE

# K072678

510(k) Summary

| Contact: | Mr. Hartmut Loch<br>Regulatory Consultant<br>c/o Allez Spine, LLC.<br>2301 DuPont Drive, Suite 510<br>Irvine, CA 92612 | JUL - 2 2008 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Trade name: | LAGUNA™ Size 8 Pedicle Screw | |
| Common name: | Spinal Fixation System | |
| Classification<br>name: | Spinal Interlaminal Fixation Orthosis - § 888.3050 (KWP) – Class II<br>Orthosis, Spinal Pedicle Fixation - § 888.3070 (MNI) – Class II<br>Orthosis, Spondylolisthesis Spinal Fixation - § 888.3070 (MNH) – Class II<br>Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease - § 888.3070 (NKB) – Class III<br>All Orthopedic Device Panel 87 | |
| Product Code: | KWP, MNI, MNH & NKB | |
| Device Description<br>and Characteristics: | The LAGUNA™ Size 8 Pedicle Screws are intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct<br>to fusion of the thoracic, lumbar and/or sacral space in conjunction with the<br>Allez Spine LAGUNA™ Polyaxial Pedicle Screw System. The<br>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. The Allez Spine<br>LAGUNA™ Polyaxial Pedicle Screw System (K050060) was cleared for<br>marketing on May 4, 2005. The LAGUNA™ Size 8 Pedicle Screws are<br>available in eleven sizes ranging from 30 mm to 100 mm are fabricated from<br>medical grade titanium alloy described by such standards as ASTM F136 or<br>ISO 5832-3 or 5832-2. | |
| Equivalence: | LAGUNA™ Size 8 Pedicle Screws are substantially equivalent to the<br>LAGUNA™ Pedicle Screw System K050060 - S/E May 4, 2005 | |
| Indications: | The LAGUNA™ Spinal System is intended to be used as an adjunct to<br>fusion using autograft or allograft in posterior, non-cervical pedicle fixation<br>for the following conditions: degenerative disc disease (defined as back pain<br>of 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. | |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL - 2 2008

Allez Spinc, LLC % Mr. Hartmut Loch Regulatory Consultant 2301 DuPont Drive, Suite 510 Irvine, CA 92612

Re: K072678

Trade/Devicc Name: LAGUNA™ Size 8 Pedicle Screw Regulation Number: 21 CFR 888.3070 Regulation Namc: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWP Dated: May 28, 2008 Received: June 3, 2008

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 (Spccial 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.

{2}------------------------------------------------

## Page 2 – Mr. Hartmut Loch

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Mark H. Mullison

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

### K072678 510(k) Number:

Device Name(s):

LAGUNA™ Size 8 Pedicle Screw

Indications for Use:

The LAGUNA™Spinal System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical pedicle 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.

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

Over-The-Counter-Use _ (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Of Division of General. Restora and Neurological De 510(k) Number