Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The CONQUEST Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the CONQUEST Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

Device Description

The CONQUEST Spinal System is a titanium alloy multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of rods, screws, and locking caps.

AI/ML Overview

This 510(k) summary describes a spinal implant system, not an AI/ML powered medical device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test sets and training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable in this context.

However, I can provide the available information regarding the device's acceptance criteria and the study performed as described in the provided text.

Acceptance Criteria and Device Performance for CONQUEST® Spinal System

Acceptance Criteria	Reported Device Performance
Biomechanical performance in accordance with ASTM F1717	Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.
Substantial equivalence to previously cleared devices in indications for use, design, function, and materials used.	The CONQUEST® Spinal System was shown to be substantially equivalent to previously cleared devices (ARX Spinal System (K061600) and Life Spine Cross Connector (K073430)) in indications for use, design, function, and materials used.

Explanation for AI-specific questions (Not Applicable for this Device):

This device, the CONQUEST® Spinal System, is a traditional medical implant, specifically a spinal fixation system. The provided 510(k) summary focuses on demonstrating its mechanical properties and equivalence to existing, legally marketed devices. It does not involve any artificial intelligence or machine learning components for diagnosis, prognosis, or treatment decisions. Therefore, the following information is not provided nor applicable:

Sample size used for the test set and the data provenance: Not applicable. The "test set" for this type of device would refer to physical prototypes undergoing mechanical testing, not a dataset for an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is irrelevant here. The "ground truth" for a spinal implant's performance would be derived from mechanical test standards (ASTM F1717) and engineering principles.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable. This device does not involve human readers interpreting data with or without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the biomechanical performance, the "ground truth" is adherence to established engineering standards (ASTM F1717) and functional equivalence to predicate devices, rather than clinical outcomes or diagnostic ground truth.
The sample size for the training set: Not applicable. This device does not involve a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Ko80767

510(k) Summary

MAY 2 1 2008

CONQUEST® Spinal System

Submitted By:	Life Spine2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Rebecca BrooksLife Spine2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	March 14, 2008
Trade Name:	CONQUEST® Spinal System
Common Name:	Appliance, Fixation, Spinal Interlaminal
Classification:	888.3070 Pedicle screw spinal system
Device Product Code:	MNH, 21 CFR 888.3070, Class IIMNI, 21 CFR 888.3070, Class II
Predicate Devices:	ARX Spinal System (K061600)Life Spine Cross Connector (K073430)

Device Description:

Intended Use of the Device:

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Material:

Manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6AL-4V-ELE) implant grade titanium alloy.

Performance Data:

Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.

Substantial Equivalence:

The CONQUEST® Spinal System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2008

Life Spinc % Ms. Rebecca Brooks Project Manager 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169

Re: K080767 Trade/Device Name: Conquest Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNI, MNH Dated: April 30, 2008 Received: May 6, 2008

Dear Ms. Brooks:

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.

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. Rebecca Brooks

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milligan

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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Indications for Use

510(k) number (if known): K080767

Device Name: CONQUEST® Spinal System

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)

Nilreodl foxax
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K090762

Regulation Number and Section

N/A