NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX
Applicant
Abbott Spine, Inc.
Product Code
KWP · Orthopedic
Decision Date
Sep 14, 2005
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3050
Device Class
Class 2
Attributes
Therapeutic
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 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 use of multiaxial screws are not intended to be placed in the cervical spine.
Device Story
Nex-Link Spinal Fixation System is a posterior spinal implant system consisting of longitudinal members, hooks, rods, and multiaxial screws. Designed for fixation and stabilization of the cervical and upper thoracic spine (C1-T3) to promote fusion. Subject device is a Variable Crosslink modification to the predicate system. Used by surgeons in clinical settings to stabilize the spine following trauma or degenerative conditions. Provides mechanical support to the spinal column; facilitates fusion. Operates via standard orthopedic fixation principles; no electronic or software components.
Clinical Evidence
No clinical data was required or provided for this submission. Substantial equivalence was established through non-clinical laboratory and bench testing.
Technological Characteristics
Posterior spinal fixation system consisting of longitudinal members, hooks, rods, and multiaxial screws. Mechanical fixation device. No energy source, software, or connectivity. Sterilization method not specified.
Indications for Use
Indicated for patients requiring cervical and thoracic (C1-T3) spinal fusion due to DDD (discogenic neck pain with confirmed degeneration), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, or tumors. Hooks and rods indicated for stabilization following trauma. Multiaxial screws restricted to T1-T3 thoracic use; contraindicated for cervical spine placement.
Regulatory Classification
Identification
A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
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## ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS
| SUBMITTER: | Abbott Spine (formerly Spinal Concepts, Inc.) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT REGISTRATION<br>NUMBER: | 1649384 |
| CONTACT PERSON: | Noah Bartsch<br>Specialist, Regulatory Affairs |
| | Telephone: 512.533.1840 |
| | Fax: 512.918.2784 |
| DATE: | August 17, 2005 |
| TRADE NAME: | Nex-Link Spinal Fixation System Variable<br>Crosslink |
| COMMON NAME: | Posterior Spinal Implant |
| CLASSIFICATION NAME: | KWQ: Spinal Intervertebral Body Fixation 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 The Nox Emic Spine (C1-T3). The system consists of a series of longitudinal members, ecerviconomics (Sectors, and instruments for inserting and securing the implants.
The subject device, the Variable Crosslink, represents a design modifications made to the The subject device, the Nations or others. The subject device shares the same intended use and fundamental scientific technology as the predicate.
#### INDICATIONS:
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:
{1}------------------------------------------------
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and DDD (neck pain of discogeme origin with degeneratives et eture, dislocation, failed previous fusion and/or tumors.
Hooks and rods are also intended to provide stabilization to promote fusion following reduction TIORS and Tods are arso intended we 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 use of maniantal betern is timended to be placed in the cervical spine.
| COMPARISON TO PREDICATE DEVICE: | The subject device is the result of design<br>modifications to the predicate device, has the same<br>intended use, and is substantially equivalent to the<br>predicate device. |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PERFORMANCE DATA (NONCLINICAL<br>AND/OR CLINICAL): | NON-CLINICAL PERFORMANCE AND CONCLUSIONS: |
| | Laboratory and bench testing results demonstrate<br>that the proposed device is substantially equivalent<br>to the predicate device. |
| | CLINICAL PERFORMANCE AND CONCLUSIONS: |
| | Clinical data and conclusions were not needed for<br>this device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.
SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Noah Bartsch Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727
Re: K052247
Trade Name: Nex-Link™ Spinal Fixation System Variable Crosslink Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNI, KWP Dated: August 17, 2005 Received: August 18, 2005
Dear Mr. Bartsch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the Medical Device Amendments, or to conninered prior to ria) 2011-07-12 in accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Cosmetic For (110) and the device, subject to the general controls provisions of the Act. The r ou may, dierelore, manner of the Act include requirements for annual registration, listing of general controls pro resuring 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 If your device is elassified (vor a controls. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 loase oc advised that 1 Dr b resumerat your device complies with other requirements of the Act that IDA has made a acternmentations administered by other Federal agencies. You must of ally if cach statutes and regarations sincluding, but not limited to: registration and listing (21 Comply with an the Act 81 equinements, and manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 forth in the quality systems (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) I his letter will anow you to begin manieting your manieting of your device to a legally premarket notification: "The PDF intentig gour 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 If you desire specific advice for your as (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Complanes as (est notification" (21CFR Part 807.97). You may obtain Misoraliums by releveloc to premanse robilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Car Mark N. Melkerson 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 (if known): K052247
Device Name: 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 DDD (neck pain of discogeme oright my spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and rods are also intended to provide stabilization to promote fusion following Hooks and rous are uiso intentiou to 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 The use of multiaxial screws are not intended to be placed in the cervical spine.
Prescription Use _X_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of General, Resund and Neurological Devices
Page 1 of 1
**510(k) Number** K052247
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