SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM

K031985 · Spinal Concepts, Inc. · MNI · Sep 11, 2003 · Orthopedic

Device Facts

• Record ID: K031985
• Device Name: SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
• Applicant: Spinal Concepts, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Sep 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

Device Story

Posterior spinal fixation system; consists of longitudinal members, anchors, and transverse connectors. Used for stabilization and fusion of C1-T3 spine. Implants surgically placed by physicians to treat degenerative conditions, trauma, or tumors. Provides mechanical stabilization to promote bone fusion. Multiaxial screws limited to T1-T3 thoracic applications.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F1717-01 and ASTM F1798-97 to demonstrate structural integrity and equivalence to predicate.

Technological Characteristics

Materials: Ti-6A1-4V ELI titanium alloy (ASTM F-136) or commercially pure titanium (ASTM F-67). Components: longitudinal members, anchors, transverse connectors, multiaxial screws. Mechanical testing per ASTM F1717-01 and ASTM F1798-97.

Indications for Use

Indicated for patients requiring cervical/thoracic (C1-T3) spinal fusion/stabilization due to DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed fusion, or tumors. Multiaxial screws restricted to T1-T3 thoracic use only; not for cervical spine.

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

• Medtronic Sofamor Danek VERTEX™ Reconstruction System

Submission Summary (Full Text)

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SEP 1 1 2003

## Spinal Concepts, Inc. Nex-Link Spinal Fixation System

### 510(k) Summary

| SUBMITTED BY | Spinal Concepts, Inc.<br>5301 Riata Park Court, Bldg. F<br>Austin, TX 78727 | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT<br>REGISTRATION NUMBER | 1649384 | |
| CONTACT PERSON | Primary<br>Lisa Peterson<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] | Alternate<br>David M. Hooper, Ph.D.<br>Director, Clinical and<br>Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED | June 26, 2003 | |
| CLASSIFICATION NAME | KWP - Spinal Interlaminal Fixation Orthosis<br>MNI - Pedicle Screw Spinal System<br>MNH – Spondylolisthesis Spinal Fixation Device System<br>NKB - Pedicle Screw Fixation System, DDD | |
| COMMON NAME | Posterior Spinal Implant | |
| PROPRIETARY NAME | Spinal Concepts Inc. Nex-Link Spinal Fixation System | |
| PREDICATE DEVICE | Medtronic Sofamor Danek VERTEX™ Reconstruction System | |

### DEVICE DESCRIPTION

The Spinal Concepts, Inc. Nex-Link Spinal Fixation System consists of a series of longitudinal members, anchors, and transverse connectors. The Nex-Link system is intended for fixation to, and stabilization of, the cervicothoracic spine.

Nex-Link implants are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F-136 or commercially pure titanium per ASTM-F-67.

## INDICATIONS:

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

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Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

# MECHANICAL TEST DATA

Mechanical testing data, collected in accordance with ASTM F1717-01 and ASTM F1798-97, were provided to support this 510(k) notification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is written around the perimeter of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2003

Ms. Lisa Peterson Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727

Re: K031985 Trade Name: Nex-Link Spinal Fixation System Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNI, KWP Dated: June 26, 2003 Received: July 9, 2003

Dear Ms. Peterson:

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 maior 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.

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Page 2 - Ms. Lisa Peterson

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 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost
for

Celia M. Witten, Ph.D., M.D. 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

510(k) Number (if known): K031985

Device Name:

Spinal Concepts, Inc. Nex-Link Spinal Fixation System

Indications for Use:

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR

Over-The-Counter: (Optional Format 1-2-96)

Muriam C. Provost

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

510(k) Number K031985