The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (CONCORDE, CONCORDE Bullet), TLIF (CONCORDE, CONCORDE Bullet, CONCORDE Curve, DEVEX, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.

The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation products.

Device Description

The Concorde Curve System consists of polymer/carbon fiber composite cages and implantation instruments. Cages are available in varying shape and size configurations to match patient anatomy. The polymer/carbon fiber cage structure is radiolucent with tantalum x-ray markers so that healing can be assessed by normal radiographic methods. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Biomechanical performance after gamma sterilization equivalent to predicate device	"Testing was performed to determine the effects of gamma radiation on the cages. The testing was performed in compliance with ASTM F2077, static axial and dynamic axial testing was performed to demonstrate substantial equivalence post-sterilization and again with the predicate device."

Explanation of Implied Acceptance Criteria: The document states that "The proposed device is identical to the predicate device except that the proposed device will be terminally sterilized by DePuy Spine." and aims to demonstrate "substantial equivalence post-sterilization and again with the predicate device." This implies that the core acceptance criteria for the new device are that its performance (specifically, biomechanical properties) should not be negatively altered by the sterilization process and should remain substantially equivalent to the previously cleared predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document only mentions "Testing was performed" for "cages" without specifying the number of samples.
Data Provenance: Not explicitly stated, but the nature of the tests (static axial and dynamic axial testing) suggests laboratory-based, prospective testing of manufactured samples. There is no indication of retrospective or country-of-origin data from patient populations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable to this type of device and study. The "ground truth" for the biomechanical performance of orthopedic implants is typically established through standardized physical testing methods (like ASTM F2077) and engineering specifications, not expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. Biomechanical testing does not involve human adjudication in the typical sense of clinical trials or image interpretation. The outcome is determined by physical measurements and adherence to test standards.

5. 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 is not an AI/imaging device. The study described is a physical performance evaluation of an implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithm device. The "device" is a physical intervertebral body fusion system.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established physical and mechanical performance parameters defined by the ASTM F2077 standard for static axial and dynamic axial testing, as well as the pre-sterilization performance of the predicate device. The goal was to demonstrate that the sterilized device met these pre-defined physical performance benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of device.

Summary

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103743

510(K) SUMMARY

	MAR 17 2011
Submitter:	DePuy Spine, Inc.
	325 Paramount Drive
	Raynham, MA 02767
Contact Person:	Eugene Bang
	Regulatory Affairs Associate
	Voice: (508) 977-3966
	Fax: (508) 828-3797
	Email: ebang@its.jnj.com
Date Prepared:	December 21, 2010
Trade Name:	CONCORDE® Curve System
Device Class:	Class II
Product Code(s):	MAX, MQP
Classification Name:	Intervertebral Body Fusion Deviceper 21 CFR §888.3080
	Spinal Intervertebral Body Fixation Orthosisper 21 CFR §888.3060
Predicate Device:	CONCORDE® Curve System ( K101923)
Device Description:	The Concorde Curve System consists of polymer/carbon fiber compositecages and implantation instruments. Cages are available in varyingshape and size configurations to match patient anatomy. Thepolymer/carbon fiber cage structure is radiolucent with tantalum x-raymarkers so that healing can be assessed by normal radiographic methods.The cages have ridges or teeth that resist rotation and migration andhave cavities to accept packing of bone graft.

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Page 1 of 3

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Intended Use:

Materials:

Technological Characteristics:

The CONCORDE® Curve System is made from carbon-fiber reinforced polymer with tantalum wires.

The purpose of this submission is to obtain market clearance for the proposed sterile components to the CONCORDE® Curve System. The proposed device is identical to the predicate device except that the proposed device will be terminally sterilized by DePuy Spine. The design characteristics, performance, intended use, materials, and technology remain identical to the predicate system.

DePuy Spine, Inc., a Johnson & Johnson Company

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Performance Data:

Testing was performed to determine the effects of gamma radiation on the cages. The testing was performed in compliance with ASTM F2077, static axial and dynamic axial testing was performed to demonstrate substantial equivalence post-sterilization and again with the predicate device.

Conclusion:

Based on the predicate comparison and testing, the subject device CONCORDE® Curve System is substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DePuy Spine, Inc. % Mr. Eugene Bang Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

MAR 1 7 201

Re: K103743

Trade/Device Name: CONCORDE® Curve System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: February 15, 2011 Received: February 16, 2011

Dear Mr. Bang:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

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Page 2 - Mr. Eugene Bang

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), pleáse go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

$\tau*{2}$ B. $D*{2}h$

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative 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): C103743

Device Name: CONCORDE® Curve System

Indications For Use:

Prescription Use X

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(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)

(Division Sign-Off) Division of Survice! Orthopedic. and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.