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., TI-LS) 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 Bullet Spinal System contains cages featuring a bulleted nose to aid in insertion into the vertebral body. The CONCORDE Bullet Spinal System proposed additional cages are offered in carbon fiber reinforced polymer material. They are available in various geometries and sizes to accommodate patient anatomy.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the CONCORDE Bullet Spinal System:

The document K110694 is a 510(k) summary for the CONCORDE Bullet Spinal System. This submission is for modifications to an existing device, specifically the inclusion of new cage heights and lengths.

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This is achieved by showing that the modified device is as safe and effective as the predicates, and performs comparably.

The performance data submitted was for mechanical testing of the device.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Material Equivalence	Materials are identical to predicate devices.	Manufactured from carbon-fiber reinforced polymer with tantalum wires, identical to predicate systems.
Design Equivalence	Design remains identical to predicate devices, with only minor differences in sizes.	Design remains identical to predicate systems, with the only change being new heights and lengths of cages.
Technological Equivalence	Technology remains identical to predicate devices.	Technology remains identical to predicate systems.
Biomechanical Performance	Device must meet established biomechanical standards to ensure structural integrity and function.	Performance data per ASTM F 2077 was submitted. This included: - Static compression testing - Dynamic compression testing - Static torsion testing - Dynamic torsion testing
Safety and Effectiveness	Device is as safe and effective as the predicate device.	The submission concludes that "Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device."

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

Sample Size: Not explicitly stated. For mechanical testing per ASTM F 2077, the sample size would typically be a small number of physical devices tested to failure or under specified load conditions. The exact number of units tested is not provided in this summary.
Data Provenance: The testing was conducted in a laboratory setting to characterize the physical and mechanical properties of the device components. The geographical origin of this testing is not specified, but it would typically be performed by the manufacturer or an accredited testing facility. This is prospective data collection in the sense of specifically designed tests, rather than retrospective analysis of patient data.

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

This type of submission for an intervertebral body device typically relies on engineering and material science expertise to establish performance criteria and interpret test results. It does not involve "experts" in the clinical sense (e.g., radiologists) for establishing ground truth of image interpretation. The "ground truth" here is the adherence to mechanical standards and material specifications.

4. Adjudication Method for the Test Set:

Not applicable in the context of mechanical performance testing. Mechanical tests have objective endpoints measured by equipment, not subjective reviewer adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical and material equivalence of a medical implant, not clinical diagnostic performance or interpretation by human readers.

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

Not applicable. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this submission is objective mechanical performance data from tests adhering to ASTM F 2077 standards, combined with detailed material specifications and design documentation. The "truth" is whether the device meets predefined engineering requirements and matches the characteristics of its predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical implant, and there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are informed by established engineering principles and prior device iterations, not a machine learning training dataset.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no corresponding method for establishing its ground truth. The design and validation of the device are based on engineering standards and scientific understanding of biomechanics.

Summary

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K110694 1 of 3

510(K) SUMMARY

OCT 1 1 2011

A. Submitter Information
DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767

Daphney Germain-Kolawole Contact Person: Regulatory Affairs Associate Voice: (508) 880-8395 (508) 828-3797 E-Mail: dgermain@its.jnj.com

B. Date Prepared 3/11/2011
C. Device Name

Fax:

Trade/Proprietary Name: CONCORDE Bullet Spinal System Common/Usual Name: Intervertebral Body Device Classification Name: Spinal intervertebral body fixation orthosis per 21 CFR §888.3060 Intervertebral body fusion device per 21 CFR §888.3080

D. Predicate Device Name

Trade name: LUMBAR I/F CAGE® (P960025) CONCORDE® VBR Spinal System (K052746) DePuy Spine Cages (K081917)

DePuy Spine, Inc., a Johnson & Johnson Company

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K110694 2 of 3

Device Description E.

F. 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 history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of nonoperative 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.

DePuy Spine, Inc., a Johnson & Johnson Company

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K110694- 3 of 3

Summary of Similarities and Differences in Technological Characteristics, F. Performance and Intended Use

The proposed modifications to the DePuy Spine CONCORDE Bullet Spinal System are identical to the predicate devices with one minor difference. The only change is the inclusion of cages of differing heights and lengths that were not originally cleared in the predicate 510k. The design, materials, and technology remain identical to the predicate systems.

હ. Materials

Manufactured from carbon-fiber reinforced polymer with tantalum wires.

H. Performance Data

Performance data per ASTM F 2077 were submitted to characterize the subject CONCORDE Bullet Spinal System components addressed in this notification. Specifically, static and dynamic compression testing as well as static and dynamic torsion testing were performed.

l. Conclusion

Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like shapes. The bird is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 1 1 2011

DePuy Spine, Inc. % Ms. Daphney Germain-Kolawole Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K110694

Trade/Device Name: CONCORDE Bullet Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MOP Dated: September 22, 2011 Received: September 23, 2011

Dear Ms. Germain-Kolawole:

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, Trug, 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 contractly and 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 af the Act

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Page 2 - Ms. Daphney Germain-Kolawole

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 (reporting of marinal device-related adverse events) (21 CFR 803); good manufacturing practice requirements as st 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 100-1000.

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/ucm 1 1 800 7, please 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" (211758) Prot 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,

Peter

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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KII 0694

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: CONCORDE® Bullet Spinal System

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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 Surgical, Orthopedic, and Restorative Devices

K110694 510(k) Number_

DePuy Spine, Inc., a Johnson & Johnson Company

Page 18

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.