ALLEZ SPINE CROSS CONNECTORS

K070460 · Allez Spine, LLC · NKB · Jun 11, 2007 · Orthopedic

Device Facts

• Record ID: K070460
• Device Name: ALLEZ SPINE CROSS CONNECTORS
• Applicant: Allez Spine, LLC
• Product Code: NKB · Orthopedic
• Decision Date: Jun 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ALLEZ SPINE Cross Connectors are intended to help provide and correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine Laguna Polyaxial Pedicle Screw System.

Device Story

ALLEZ SPINE Cross Connectors provide immobilization and stabilization of spinal segments as an adjunct to fusion; used in thoracic, lumbar, and sacral regions. Device functions as a component of the Laguna Polyaxial Pedicle Screw System; rods and screws are locked into configurations tailored to individual patient anatomy. Available in three sizes (37mm, 50mm, 80mm). Implanted by surgeons during spinal fusion procedures to correct spinal deformities or stabilize segments; provides mechanical support to facilitate bone fusion and patient recovery.

Clinical Evidence

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

Technological Characteristics

Fabricated from medical grade titanium alloy (ASTM F136, ISO 5832-3, or ISO 5832-2). Mechanical fixation device; available in 37mm, 50mm, and 80mm sizes. Designed for use with the Laguna Polyaxial Pedicle Screw System.

Indications for Use

Indicated for posterior, non-cervical pedicle fixation in patients with degenerative disc disease (back pain of discogenic origin confirmed by history/radiographic studies), spondylolisthesis, trauma (fracture or 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

• Blackstone Spinal Fixation System, Second-Generation Cross-Connector (K003735)

Reference Devices

• Allez Spine Laguna Polyaxial Pedicle Screw System (K050060)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

[in accordance with SMDA of 1990, 21 CFR 807.92(c)]

- 070460 Mr. Hartmut Loch, RAC Contact: Regulatory Consultant Official FDA Correspondent c/o Allez Spine, LLC. JUN 1 1 2007 2301 DuPont Drive, Suite 510 Irvine, CA 92612 ALLEZ SPINE Cross Connectors Trade name: Spinal Fixation Cross Connector Common name: Appliance, Fixation, Spinal Intervertebral - § 888.3060 (KWQ, KWP) Classification Orthosis, Spinal Pedicle Fixation - § 888.3070 (MNI, NKB) name: Orthosis, SpondylolisthesisSpinal Fixation - § 888.3070 (MNH) Class III, Orthopedic Device Panel 87 KWQ, MNI, KVVP, NKB & MNH Product Code: Device Description The ALLEZ SPINE Cross Connectors are intended to help provide and Characteristics: correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine Laguna Polyaxial Pedicle Screw System. The Laguna Spinal System consists of a variety of rods and screws. which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Allez Spine Laguna Polyaxial Pedicle Screw System (K050060) was cleared for marketing on May 4, 2005. The ALLEZ SPINE Cross Connectors are available in three sizes: small (37 mm), medium (50 mm) and large (80 mm) and are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2. Allez Spine ALLEZ SPINE Cross Connectors is substantially equivalent to Equivalence: the Blackstone Spinal Fixation System, Second-Generation Cross-Connector K003735 S/E May 8, 2001 The ALLEZ SPINE Cross Connectors are intended for posterior, non-Indications: cervical fixation in conjunction with the Allez Spine Laguna Pedicle Screw System 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. Biomechanical tests have been performed. The test results were equivalent Performance data: to other similar implants and are sufficient for in vivo loading.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Allez Spine, L.L.C. c/o Mr. Hartmut Loch Regulatory Consultant 2301 Dupont Drive, Suite 510 Irvine, California 92612

JUN 1 1 2007

Re: K070460

> Trade/Device Name: Allez Spine Cross Connectors Regulation Number: 21 CFR §888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP and KWQ Dated: April 24, 2007 Received: April 27, 2007

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 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.

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Page 2 - Mr. Hartmut Loch

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 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 [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 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 N. Melkerson

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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Page _1 ______________________________________________________________________________________________________________________________________________________________________

510(k) Number: K070460

Device Name(s):

ALLEZ SPINE Cross Connectors

## Indications for Use:

The LAGUNA SPINAL SYSTEM is intended for 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; connimed by filetery or dislocation), spinal stenosis; curvatures trauma (1.0.huotare failed previous fusion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional format 1-2-96)

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative, and Neurological Devices

510(k) Number L070466