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 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.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a spinal fixation system, not an AI/ML medical device. Therefore, the information requested in the prompt, such as acceptance criteria, performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is not applicable to this document.

The document discusses the substantial equivalence of the "Nex-Link Spinal Fixation System" to a predicate device based on design modifications and non-clinical performance (laboratory and bench testing). It explicitly states: "Clinical data and conclusions were not needed for this submission."

Therefore, I cannot provide the requested information as it pertains to AI/ML device studies.

Summary

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2006 JAN 6

ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTER:	Abbott Spine Inc.(formerly Spinal Concepts, Inc.)
ESTABLISHMENT REGISTRATIONNUMBER:	1649384
CONTACT PERSON:	Noah BartschSpecialist, Regulatory AffairsTelephone: 512.533.1840Fax: 512.918.2784
DATE:	September 16, 2005
TRADE NAME:	Nex-Link Spinal Fixation SystemPolyaxial Screws, Open Hooks
COMMON NAME:	Posterior Spinal Implant
CLASSIFICATION NAME:	KWQ: Spinal Intervertebral Body FixationOrthosisMNI: Pedicle Screw Spinal System
CLASSIFICATION REFERENCE:	21 CFR § 888.3050, 888.3070
PREDICATE DEVICE:	Spinal Concepts, Inc. (now Abbott Spine, Inc.)Nex-Link Spinal Fixation System, K031985,cleared September 11, 2003.

DEVICE DESCRIPTION:

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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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)

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

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510(k) Number | K052566

Regulation Number and Section

N/A