NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY

K052566 · Abbott Spine, Inc. · MNI · Jan 6, 2006 · Orthopedic

Device Facts

• Record ID: K052566
• Device Name: NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY
• Applicant: Abbott Spine, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Jan 6, 2006
• Decision: SESE
• Submission Type: Special
• 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 Nex-Link 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

Nex-Link Spinal Fixation System provides posterior spinal fixation and stabilization for cervicothoracic spine (C1-T3). System comprises longitudinal members (rods), anchors (polyaxial screws, hooks), transverse connectors, and surgical instrumentation. Designed for use by surgeons in clinical settings to promote spinal fusion. Subject devices represent design modifications to previously cleared Abbott Spine implants. Operates via mechanical fixation to stabilize spinal segments; does not involve electronic or software-based processing. Benefits include structural support for fusion in patients with degenerative disc disease, trauma, or spinal instability. Clinical decision-making relies on surgeon assessment of radiographic and patient history.

Clinical Evidence

No clinical data was required or provided for this submission. Substantial equivalence was established through laboratory and bench testing.

Technological Characteristics

Posterior spinal fixation system consisting of longitudinal rods, polyaxial screws, hooks, and transverse connectors. Mechanical fixation device. No electronic components, software, or energy sources. Materials and sterilization methods are consistent with previously cleared predicate devices.

Indications for Use

Indicated for patients requiring cervical and thoracic (C1-T3) spinal fusion due to DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, or tumors. Hooks and rods indicated for stabilization following trauma/fracture/dislocation (C1-T3). Multiaxial screws restricted to T1-T3 thoracic conditions; contraindicated for cervical spine placement.

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

• Nex-Link Spinal Fixation System (K031985)

Submission Summary (Full Text)

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#### 2006 JAN 6

## ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS

| SUBMITTER: | Abbott Spine Inc.<br>(formerly Spinal Concepts, Inc.) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT REGISTRATION<br>NUMBER: | 1649384 |
| CONTACT PERSON: | Noah Bartsch<br>Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| DATE: | September 16, 2005 |
| TRADE NAME: | Nex-Link Spinal Fixation System<br>Polyaxial Screws, Open Hooks |
| COMMON NAME: | Posterior Spinal Implant |
| CLASSIFICATION NAME: | KWQ: Spinal Intervertebral Body Fixation<br>Orthosis<br>MNI: Pedicle Screw Spinal System |
| CLASSIFICATION REFERENCE: | 21 CFR § 888.3050, 888.3070 |
| PREDICATE DEVICE: | Spinal Concepts, Inc. (now Abbott Spine, Inc.)<br>Nex-Link Spinal Fixation System, K031985,<br>cleared September 11, 2003. |

### DEVICE DESCRIPTION:

The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants.

The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior spine. The subject devices share the same intended use and fundamental scientific technology as the predicates.

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#### 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.

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.

The subject devices are the result of design COMPARISON TO PREDICATE DEVICE: modifications to the predicate devices; they have the same intended use and are substantially equivalent to the predicate devices. Non-Clinical Performance and PERFORMANCE DATA (NONCLINICAL Conclusions: AND/OR CLINICAL): Laboratory and bench testing results demonstrate that the proposed devices are substantially equivalent to the predicate devices. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three distinct, curved lines representing its wings or body. Encircling the symbol is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular fashion.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 JAN 6

Mr. Noah Bartsch Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727

Re: K052566

Trade Name: Nex-Link™ Spinal Fixation System - Addition of Open Polyaxial Screws and Hooks Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNI. KWP Dated: December 12, 2005 Received: December 13, 2005

Dear Mr. Bartsch:

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 reclassifyed 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 fourther 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 comprise of 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. Bartsch

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 deyice 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/industry/support/index.html.

Sincerely yours,

Signature

Mark N. Melkerson 10 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 : KO52566

Device Name: Abbott Spine Incorporated's Nex-Link Spinal Fixation System - Addition of Open Polyaxial Screws and Hooks

Indications For Use:

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Nex-Link 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 (Cl-T) spine.

The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not into Placement intern 19 to treadly through

Prescription Use X (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)

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

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**510(k) Number** | K052566