LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM

K083826 · Allez Spine, LLC · MNH · Jan 22, 2009 · Orthopedic

Device Facts

• Record ID: K083826
• Device Name: LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM
• Applicant: Allez Spine, LLC
• Product Code: MNH · Orthopedic
• Decision Date: Jan 22, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LAGUNA® Polyaxial Pedicle Screw 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® Polyaxial Pedicle Screw System provides posterior, non-cervical spinal stabilization and immobilization as an adjunct to fusion. System consists of titanium alloy rods and polyaxial screws (winged/non-winged configurations; 5mm, 6mm, 7mm diameters). Components are rigidly locked into configurations tailored to individual patient anatomy. Used by surgeons in clinical settings to treat spinal pathologies including degenerative disc disease, trauma, and deformities. Device provides mechanical support to spinal segments; aids in fusion process; potentially benefits patients by correcting spinal alignment and stabilizing unstable segments.

Clinical Evidence

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

Technological Characteristics

Medical grade titanium alloy per ASTM F136. Polyaxial pedicle screws (winged/non-winged, 5-7mm diameters) and 5.5mm connecting rods. Mechanical fixation system. No software or energy source.

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

• Laguna® Pedicle Screw System (original)

Submission Summary (Full Text)

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长088826

| 510(k) Summary<br>[in accordance with SMDA of 1990, 21 CFR 807 92(c)] | | JAN 22 2009 |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact | Mr Hartmut Loch<br>Regulatory Consultant<br>Allez Spine, LLC<br>2301 Dupont Drive, Suite 510<br>Irvine CA 92612 | |
| Trade name | Allez Spine Laguna® Polyaxial 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, Spondylolisthesis Spinal Fixation - § 888 3070 (MNH)<br>All Class II,-Orthopedic-Device-Panel 87 | |
| Product Code | KWP, KWQ, MNI & MNH | |
| Device Description and Characteristics | The Laguna® Polyaxial Pedicle Screw System is intended to help provide<br>correction, immobilization and stabilization of spinal segments as an adjunct<br>to fusion of the thoracic, lumbar and/or sacral space | |
| | The LAGUNA® Polyaxial Pedicle Screw System consists of a variety of rods<br>and screws, which can be rigidly locked into a variety of configurations, with<br>each construct being tailor made for the individual case Multi axial screws<br>are supplied in winged and non-winged configurations, in a variety of<br>different length, and in 5mm, 6mm, and 7mm diameter sizes All sizes are<br>able to receive 5 5mm connecting rods only | |
| | The LAGUNA® Polyaxial Pedicle Screw System implant components are<br>fabricated from medical grade titanium alloy per ASTM F136 | |
| Equivalence | The modified Laguna® Polyaxial Pedicle Screw System is substantially<br>equivalent to the original Laguna® Pedicle Screw System, which is<br>manufactured and marketed by Allez Spine, LLC | |
| Indications | The LAGUNA® Polyaxial Pedicle Screw System is intended for posterior,<br>non-cervical fixation for the following conditions degenerative disc disease<br>(defined as back pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies), spondylolisthesis, trauma<br>(i e fracture or dislocation), spinal stenosis, curvatures (i e scoliosis,<br>kyphosis and/or lordosis), tumor pseudarthrosis, and/or failed previous<br>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 | |

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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 eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Allez Spine, LLC % Mr Hartmut Loch 2301 Dupont Drive, Suite 510 Irvine, CA 92612

JAN 2 2 2009

Re K083826

Trade/Device Name Laguna Polyaxial Pedicle Screw System Regulation Number 21 CFR 888 3070 Regulation Name Pedicle Screw Spinal System Regulatory Class II Product Code MNH, MNI, KWP, KWQ Dated December 16, 2008 Received December 23, 2008

Dear Mr Loch

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bection DTQ(t) pressured is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Ior use stated in the encrosure) to regard actives the Medical Device Amendments, or to commence prior to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have occh rechasinou in assessor as a premarket approval approval approval approval on of the Act and Cosment Act (Act) that to not roquite approvine controls provisions of the Act The You may, therefore, market the device, baojos to the manual regustration, listing of general controls provisions of the free hereforms against misbranding and adulteratıon

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Sec above) into c. Existing major regulations affecting your device . EDA it may be subject to sach additional veness, Title 21, Parts 800 to 898 In addition, FDA Can be louid in the Ood of I clerits concerning your device in the Federal Register

Please be advised that FDA's issuance of a substantial equivalence determination custo of the of the of Please be auvised that FDA 3 issualloo or a bacevae complies with other requrements of the Act
that FDA has made a determination that your device complies with other required that FDA has made a decormination and regulations administered by other Federal agencies You must or any Federal statutes and regulations anning, but not himited to registration and Issung (21 CFR Part 807), labeling (21 CFR Part 801), good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 801), good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820), and 11 app 1000, 1050 form in the quality systems (QS) regulations 531-542 of the Act), 21 CFR 1000-1050

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## Page 2 - Mr Hartmut Loch

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and it you to began finding of substantial equivalence of your device to a legally premaired 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 rr you dente eperies and Radiological Health's (CDRH's) Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to (2-0) 270 0116 - 1100) Processor 97) For questions regarding postmarket surveillance, premarker nothoution - (21021) Surveillance and Brometric's (OSB's) Division of Postmarket please connect CDACA - For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems (Nedersal 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 toll-free number [phone] or [phone] or the Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours,

Mark M Mulhearn

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

510(k) Number (if known)

Device Name(s) LAGUNA® Polyaxıal Pedicle Screw System

Indications for Use

1

The LAGUNA® Polyaxial Pedicle Screw 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 scollosis, kyphosis and/or lordosis), tumor pseudarthrosis, and/or falled previous fusion

Prescription Use _V AND/OR

Over-The-Counter-Use_

(Part 21 CFR 801 Subpart D)

(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)

MilReagl L. Nixon

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083826

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