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

CONCORDE® Curve System consists of cages of various sizes. This system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

AI/ML Overview

Here's an analysis of the provided text regarding the CONCORDE® Curve System, focusing on acceptance criteria and supporting studies:

This submission is a 510(k) premarket notification for an intervertebral body fusion device. For such devices, acceptance criteria and performance data typically relate to their biomechanical properties and how they compare to legally marketed predicate devices. The document explicitly states the purpose of the submission is "to obtain market clearance for the proposed components to the CONCORDE® Curve System" and that "The key difference between the subject and predicate devices is the addition of various sizes of the implants." It further clarifies that "These proposed components have the same design characteristics, performance, intended use, and packaging as the predicate devices."

This context is crucial: the study is not about evaluating a new type of device or a new principle of operation, but rather confirming that new sizes of an existing device type maintain equivalent performance to their predicates. Therefore, the "acceptance criteria" are implicitly met by demonstrating performance equivalent to the predicate devices through standardized biomechanical testing.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device must achieve)	Reported Device Performance (What was observed)
Performs as well as predicate devices for static and dynamic compression per ASTM F2077.	Met: "The testing results demonstrated that CONCORDE® Curve implants performed as well as the predicate devices."
Performs as well as predicate devices for static and dynamic compression shear per ASTM F2077.	Met: "The testing results demonstrated that CONCORDE® Curve implants performed as well as the predicate devices."
Performs as well as predicate devices for static and dynamic torsion per ASTM F2077.	Met: "The testing results demonstrated that CONCORDE® Curve implants performed as well as the predicate devices."
Performs as well as predicate devices for subsidence per ASTM F2267.	Met: "The testing results demonstrated that CONCORDE® Curve implants performed as well as the predicate devices."

Explanation: The "acceptance criteria" are implicitly assumed to be meeting or exceeding the performance characteristics of the predicate devices in these specific biomechanical tests. The testing results demonstrated that this was achieved.

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size (number of implants tested) for each of the biomechanical tests (ASTM F2077, ASTM F2267).
- The data provenance is not explicitly stated in terms of country of origin; however, these are standardized ASTM tests, which are internationally recognized. The testing is likely conducted in a lab setting, not involving human or animal subjects in a clinical trial sense. The data would be considered prospective in the sense that the tests are specifically conducted to evaluate the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this type of submission. Biomechanical testing of implantable devices does not rely on expert consensus for "ground truth." The "ground truth" is established by the physical properties and performance measured directly by the standardized tests.
Adjudication method for the test set:
- This question is not applicable. Biomechanical tests have objective outcomes (e.g., force at failure, stiffness, displacement) and do not involve human adjudication in the way clinical studies or image interpretations might.
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:
- This is not applicable as this is a device for intervertebral fusion, not an AI or imaging-related device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as this is a physical medical implant, not an algorithm or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is derived from standardized engineering and biomechanical test results (e.g., force, displacement, cycles to failure) as defined by ASTM international standards. The performance is then compared directly to the predicate device's performance under the same standards.
The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- This is not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

KI01923

IX. 510(k) Summary

SUBMITTER:

DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02780

DEC 1 2010

CONTACT PERSON: Eugene Bang Regulatory Affairs Associate Tel: 508-977-3966 Fax: 508-828-3797 Email: ebang@its.jnj.com

DATE PREPARED: . July 8, 2010

CLASSIFICATION NAME: Intervertebral Body Fusion Device Spinal Intervertebral Body Fixation Orthosis

REGULATION NUMBER: 888.3060, 888.3080
PRODUCT CODE: MAX, MQP

DEVICE CLASS: Class II

PROPRIETARY NAME: CONCORDE® Curve System

PREDICATE DEVICES: LEOPARD® System (K081917) CONCORDE® Bullet System (K081917)

DEVICE DESCRIPTION: CONCORDE® Curve System consists of cages of various sizes.

This system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

INTENDED USE: 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 historv 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

Ps 1 of 3

{1}------------------------------------------------

K101923

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.

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

TECHNOLOGICAL CHARACTERISTICS:

The purpose of this submission is to obtain market clearance for the proposed components to the CONCORDE® Curve System. The key difference between the subject and predicate devices is the addition of various sizes of the implants. These proposed components have the same design characteristics, performance, intended use, and packaging as the predicate devices.

PERFORMANCE DATA:

The testing of the CONCORDE® Curve System was performed in accordance with the following,

Static and dynamic compression per ASTM F2077 .
Static and dynamic compression shear per ASTM F2077 .
. Static and dynamic torsion per ASTM F2077
Subsidence per ASTM F2267 .

The testing results demonstrated that CONCORDE® Curve implants performed as well as the predicate devices.

Pg 2 of 3

{2}------------------------------------------------

K101923

CONCLUSION:

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

Pg 3 of 3

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple, using black lines on a white background.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

DePuy Spine, Inc. % Mr. Eugene Bang Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02780

DEC 1 2010

Re: K101923

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. MOP Dated: November 12, 2010 Received: November 15, 2010

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 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

{4}------------------------------------------------

Page 2 - Mr. Eugene Bang

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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,

Mark N. Molkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

III. Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

CONCORDE® Curve System Device Name:

Indications For Use:

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 turnors, 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.

Prescription Use × (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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K101923 510(k) Number_

Pg 1 of 1

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.