The CONCORDE, 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 PLF (CONCORDE), TLIF (CONCORDE, 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.

The CONCORDE, 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 fora prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation.

The BENGAL System is indicated for use as an intervertebral body fusion device 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 level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation should be used.

The BENGAL System is 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is 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 this system is intended for use with DePuy Spine supplemental internal fixation.

The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1 to 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. The VBR Spinal Systems are also indicated for treating fractures of the thoracic and lumbar spine. The VBR Spinal 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. The VBR Spinal System is intended for use with supplemental internal fixation.

The Concorde VBR Spinal System is 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. The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The Concorde VBR Spinal System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Concorde VBR Spinal System is intended for use with supplemental internal fixation.

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 (1-2-51). 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., T1-1-5) 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.

The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., Tl to 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. The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The DePuy AcroMed VBR System is designed to restore the biomechanical integrity of thie anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The DePuy AcroMed VBR System is intended for use with supplemental internal fixation.

The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine(i.e., T1 to 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is 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, this system is intended for use with DePuy Spine supplemental internal fixation. The COUGAR LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

The Devex Mesh System is indicated for use in the thoracolumbar spine (TI-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. The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar · spine. The Devex Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Devex Mesh System is intended for use with supplemental internal fixation.

The Stackable Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to 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. The Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Stackable Cage System is intended for use with supplemental internal fixation.

Device Description

The BENGAL® System is a carbon fiber reinforced polymer (CFRP) interbody fusion and VBR device. The cage distracts and maintains the intervertebral height, as well as providing restoration of cervical lordosis. The range of cages available is based on natural anatomical variation.

The Bengal® Stackable System is a radiolucent, multilevel corpectomy solution that provides a system approach to restoring natural lordosis. The BENGAL® Stackable Cage System offers versatility in footprint options (3 are available), height options (18 to 66 mm increments), and lordotic angle options. The stackable cages (LRG and XLG) are held together by a titanium locking screw and nut. The titanium locking screw is used for all stackable constructs.

The CONCORDE Bullet implants. manufactured from Carbon Fiber Reinforced Polymer (CFRP), are interbody cages designed with a bulleted nose for ease of insertion into the interbody space. The CONCORDE Bullet offers optimized area for bone graft and tantalum markers.

The CONCORDE® Inline Lumbar Interbody System completes the offering within the CONCORDE® family of products with an implant designed to facilitate ease of posterior insertion and improve resistance to migration. The CONCORDE Inline is designed with a bulleted nose for ease of insertion into the interbody space and are manufactured from Carbon Fiber Reinforced Polymer (CFRP).

The COUGAR® System is an Anterior Spinal Implant System manufactured of Carbon Fiber Reinforced Polymer (CFRP). COUGAR® is available in three footprints - Small, Medium and Large and varying heights from 10-20mm. incorporates an anatomic design with 5, 10, 15, and 20 degrees of lordosis. The cages offer tantalum marker beads for radiographic location and orientation of the implant.

The COUGAR® LS Lateral Cage System consists of the PEEK/carbon fiber composite cages (CFRP).Cages are available in parallel or lordotic configurations and are available in various sizes to match patient anatomy. The cage structure is radiolucent with tantalum x-ray wire so that healing can be assessed by normal radiographic methods. The cages have teeth that resist rotation and migration and have cavities to accept packing of autogenous bone graft. The implants may be utilized in either an open or a minimally invasive surgical approach. The implants areplaced using a lateral surgical approach.

The DEVEX® System is indicated for use in the thoracolumbar spine (i.e., T1 to 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. The DEVEX® System is also indicated for treating fractures of the thoracic and lumbar spine. The DEVEX® System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The LEOPARD® System is made of carbon fiber reinforced polymer (CFRP) material that has a modulus of elasticity approximating that of cortical bone. The LEOPARD® System meets the structural requirements of anterior column support while optimizing the fusion environment through an open, load-sharing design.

The OCELOT® Stackable Cage System provides anterior column support for single or multi-level corpectomies or total vertebrectomies from T1 to 15. The system consists of one or more PEEK™ Carbon Fiber Polymer cages that are stacked to a desired height, accommodating various patient needs. The PEEK™ Carbon Fiber Reinforced Polymer material emulates the biomechanical properties of human cortical bone, optimizing the likelihood of a sound arthrodesis.

AI/ML Overview

This document describes a 510(k) premarket notification for several spinal intervertebral body fixation orthoses and intervertebral body fusion devices. The core of the submission is the addition of a sterile configuration to previously cleared non-sterile implants.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Performance data is not provided in this submission."
Therefore, there are no specific quantified acceptance criteria or reported device performance metrics in this document. The submission relies on demonstrating substantial equivalence to predicate devices.

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

No performance data is provided, so there is no test set or related sample size. The submission's core argument is that the sterile versions of the devices are identical in design, materials, indications, and technology to their non-sterile predicate devices, with the only change being the terminal sterilization via gamma radiation.

Data Provenance: Not applicable as no new performance data was generated for this submission. The devices themselves are spinal implants and would typically be used in patients.

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

Not applicable. As no new performance data was generated, there was no "test set" requiring expert ground truth establishment in the context of this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done. This type of study is typically used for diagnostic or screening devices to assess human reader performance with and without AI assistance. This submission is for spinal implants where the primary comparison relies on material and design equivalence, and the addition of sterilization, rather than interpretive performance.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance):

No standalone performance study was done. This concept is generally relevant for AI/software algorithms. This submission is for physical medical devices (spinal implants), not an algorithm.

7. Type of Ground Truth Used:

Not applicable. As no new performance data needing ground truth was generated, there's no ground truth specified in the context of this submission. The "truth" being established here is that the new sterile devices are substantially equivalent to the previously cleared non-sterile devices, primarily based on manufacturing changes (sterilization) and material properties remaining unchanged.

8. Sample Size for the Training Set:

Not applicable. This submission does not involve a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set.

Summary of the Study and "Proof" for this Specific Submission (K140759):

The "study" in this context is a substantial equivalence determination by the FDA, not a clinical or performance study in the traditional sense.

Acceptance Criteria/Core Argument: The primary acceptance criterion for this 510(k) (K140759) is that the modified devices (sterile versions) are as safe, as effective, and perform as well as their predicate devices (non-sterile versions). This is achieved by demonstrating that the only change is the addition of terminal sterilization via gamma radiation, and that the design, materials, indications for use, and technology remain identical.
Proof: The submitter "proves" this by:
- Identifying specific predicate devices for each product line (BENGAL System, OCELOT Stackable Cage System, etc.), all of which were previously cleared by the FDA for similar indications.
- Stating explicitly that "The subject devices are identical to the predicate devices... except that the subject devices will be terminally sterilized via gamma radiation. The design, materials, indications, and technology remain identical to the predicate systems."
- Confirming that "The materials of the subject implants remain unchanged from that of the previously cleared implants."
- Not providing new performance data because the change (sterilization) is considered not to alter the fundamental performance characteristics, relying instead on the established safety and effectiveness of the equivalent, non-sterile predicate devices.

In essence, the submission relies on the established regulatory history and scientific understanding that gamma sterilization, when appropriately validated, does not fundamentally alter the mechanical performance or biological safety of these types of materials/devices in a way that requires new extensive performance testing beyond demonstrating material compatibility and sterility. The FDA's clearance letter confirms their agreement with this assessment by stating that the device is "substantially equivalent."

Summary

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A. Submitter Information

Manufacturer:	Medos International SárlChemin-Blanc 382400 Le Locle, Switzerland
Submitter:	DePuy Synthes Spine325 Paramount DriveRaynham, MA 02767
Contact Person:	Linda Bernier325 Paramount DriveRaynham, MA 02767
Telephone number:	508-828-2837
Fax number:	508-828-3797
Email:	lbernier@its.jnj.com
Date Prepared	June 12, 2014

C. Device Name

Device Name > < < < < < < < < < < < < < < < < < < < < Product Code > > < < < < < < < < < < < < < < < < < < < <
BENGAL® System	888.3060, (888.3080)	MQP, (MAX, ODP)
BENGAL® Stackable System	888.3060, (888.3080)	MQP, (MAX)
DEVEX® System	888.3060, (888.3080)	MQP, (MAX)
OCELOT® Stackable Cage System	888.3060	MQP
CONCORDE® Bullet Lumbar Interbody	888.3060, (888.3080)	MQP, (MAX)
System
COUGAR® System	888.3060, (888.3080)	MQP, (MAX)
LEOPARD® System	888.3060, (888.3080)	MQP, (MAX)

Device Name - Comment Career		Regulation Number Code Code Code
CONCORDE® Inline Lumbar Interbody	888.3080	MAX
System
COUGAR® LS Lateral Cage System	888.3080	MAX

Common/Usual Name:	Spinal Intervertebral Body Fixation Orthosis (VBR)
	Intervertebral Body Fusion Device (IBF)

Spinal Intervertebral Body Fixation Orthosis Classification Name: Per 21 CFR 888.3060 Intervertebral Body Fusion Device Per 21 CFR 888.3080

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D. Predicate Device Name

Trade name:

BENGAL® System BENGAL® Stackable System CONCORDE® Bullet Lumbar Interbody System CONCORDE® Inline Lumbar Interbody System COUGAR® System COUGAR® LS Lateral Cage System DEVEX® System LEOPARD® System OCELOT® Stackable Cage System

E. Device Name and Description

BENGAL® System: The BENGAL® System is a carbon fiber reinforced polymer (CFRP) interbody fusion and VBR device. The cage distracts and maintains the intervertebral height, as well as providing restoration of cervical lordosis. The range of cages available is based on natural anatomical variation.

BENGAL® Stackable System: The Bengal® Stackable System is a radiolucent, multilevel corpectomy solution that provides a system approach to restoring natural lordosis. The BENGAL® Stackable Cage System offers versatility in footprint options (3 are available), height options (18 to 66 mm increments), and lordotic angle options. The stackable cages (LRG and XLG) are held together by a titanium locking screw and nut. The titanium locking screw is used for all stackable constructs.

CONCORDE® Bullet Lumbar Interbody System: The CONCORDE Bullet implants. manufactured from Carbon Fiber Reinforced Polymer (CFRP), are interbody cages designed with a bulleted nose for ease of insertion into the interbody space. The CONCORDE Bullet offers optimized area for bone graft and tantalum markers.

CONCORDE® Inline Lumbar Interbody System: The CONCORDE® Inline Lumbar Interbody System completes the offering within the CONCORDE® family of products with an implant designed to facilitate ease of posterior insertion and improve resistance to migration. The CONCORDE Inline is designed with a bulleted nose for ease of insertion into the interbody space and are manufactured from Carbon Fiber Reinforced Polymer (CFRP).

The COUGAR® System is an Anterior Spinal Implant System COUGAR® System: manufactured of Carbon Fiber Reinforced Polymer (CFRP). COUGAR® is available in three COUGAR® footprints - Small, Medium and Large and varying heights from 10-20mm. incorporates an anatomic design with 5, 10, 15, and 20 degrees of lordosis. The cages offer tantalum marker beads for radiographic location and orientation of the implant.

COUGAR® LS Lateral Cage System: The COUGAR® LS Lateral Cage System The COUGAR® LS Lateral Cage System consists of the PEEK/carbon fiber composite cages (CFRP).Cages are available in parallel or lordotic configurations and are available in various sizes to match

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patient anatomy. The cage structure is radiolucent with tantalum x-ray wire so that healing can be assessed by normal radiographic methods. The cages have teeth that resist rotation and migration and have cavities to accept packing of autogenous bone graft. The implants may be utilized in either an open or minimally invasive surgical approach. The implants areplaced using a lateral surgical approach.

DEVEX® System: The DEVEX® System is indicated for use in the thoracolumbar spine (i.e., T1 to 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. The DEVEX® System is also indicated for treating fractures of the thoracic and lumbar spine. The DEVEX® System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

LEOPARD® System: The LEOPARD® System is made of carbon fiber reinforced polymer (CFRP) material that has a modulus of elasticity approximating that of cortical bone. The LEOPARD® System meets the structural requirements of anterior column support while optimizing the fusion environment through an open, load-sharing design.

OCELOT® Stackable Cage System: The OCELOT® Stackable Cage System provides anterior column support for single or multi-level corpectomies or total vertebrectomies from T1 to 15. The system consists of one or more PEEK™ Carbon Fiber Polymer cages that are stacked to a desired height, accommodating various patient needs. The PEEK™ Carbon Fiber Reinforced Polymer material emulates the biomechanical properties of human cortical bone, optimizing the likelihood of a sound arthrodesis.

F. Intended Use

BENGAL® System:

This system was cleared in K081917 (VBR & IBF) on May 22, 2009. Intended Use listed respectively.

K081917

CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications.

The CONCORDE, 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

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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 fora prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation.

BENGAL System Indications

BENGAL® Stackable System:

510(k) submission K073649 cleared January 25, 2008.

K073649

The VBR Spinal Systems are also indicated for treating fractures of the thoracic and lumbar spine.

The VBR Spinal 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.

The VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDATM SR, UNIVERSITY PLATETM,M-2 ANTERIOR PLATET M , ISOLA®, VSP¢,MOSS®MIAMI, TIMX TM, MONARCH TM , EXPEDIUM TM,VIPER TM, and PROFILE TM).

CONCORDE® Bullet Lumbar Interbody System:

Original 510(k) submission K052746 (VBR) cleared October 21, 2005; subsequent K081917 (VBR & IBF) cleared May 22, 2009. Intended Use listed respectively.

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K052746

The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.

The Concorde VBR Spinal System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The Concorde VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Concorde VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, T MX, MONARCH, Expedium, Viper, and Profile).

K081917

CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications.

The CONCORDE, 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 PLF (CONCORDE), TLIF (CONCORDE, 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.

The CONCORDE, 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 anteriordecompression 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.

BENGAL System Indications The BENGAL System is indicated for use as an intervertebral body fusion device 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 level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via

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an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation should be used.

The BENGAL System is 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is 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 this system is intended for use with DePuy Spine supplemental internal fixation.

CONCORDE® Inline Lumbar Interbody System:

510(k) submission K110694 cleared October 11, 2011.

K110694

COUGAR® System:

Original 510(k) submission K030833 (VBR) cleared April 4, 2003; subsequent K081917 (VBR & IBF) cleared May 22, 2009. Intended Use listed respectively.

K030833

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The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.

The DePuy AcroMed VBR System is designed to restore the biomechanical integrity of thie anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).

K081917

CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications.

The CONCORDE, 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 PLF (CONCORDE), TLIF (CONCORDE, 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.

The CONCORDE, 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 anteriordecompression 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 fora prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation.

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collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is 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 this system is intended for use with DePuy Spine supplemental internal fixation.

COUGAR® LS Lateral Cage System:

Original 510(k) submission K082128 cleared November 14, 2008; subsequent K110454 cleared May 13, 2011. Intended Use listed respectively.

K082128

The Lateral Cage System is indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. The Lateral Cage System is intended for use with DePuy Spine supplemental fixation.

K110454

The COUGAR LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

DEVEX® System:

Original 510(k) submission K023835 (VBR) cleared January 29, 2003; subsequent K081917 (VBR & IBF) cleared May 22, 2009. Intended Use listed respectively.

K023835

The Devex Mesh System is indicated for use in the thoracolumbar spine (TI-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve

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anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar · spine.

The Devex Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Devex Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).

K081917

CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications.

The CONCORDE, 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 PLF (CONCORDE), TLIF (CONCORDE, 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.

The CONCORDE, 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 anteriordecompression 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 fora prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation.

The BENGAL System is 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

{9}------------------------------------------------

anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is 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 this system is intended for use with DePuy Spine supplemental internal fixation.

LEOPARD® System:

This system was cleared in K081917 (VBR & IBF) on May 22, 2009. Intended Use listed respectively.

K081917

CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications.

The CONCORDE, 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 PLF (CONCORDE), TLIF (CONCORDE, 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.

The CONCORDE, 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 anteriordecompression 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 fora prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation.

{10}------------------------------------------------

anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation.

OCELOT® Stackable Cage System:

510(k) submission K001340 cleared July 26, 2000.

K001340

The Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine.

The Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The Stackable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Stackable Cage System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Profile).

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

Addition of sterile configuration to previously cleared non-sterile implants now provides these devices as sterile. The subject devices are identical to the predicate devices (K073649, K081917, K052746, K110694, K030833, K082128, K122896, K110454, K023835, and K001340) except that the subject devices will be terminally sterilized The design, materials, indications, and via gamma radiation. technology remain identical to the predicate systems.

The materials of the subject implants remain unchanged from that of H. Materials the previously cleared implants. The intervertebral body fixation devices are manufactured from Carbon Fiber Filled PEEK-OPTIME LT1 Compound (CFRP), ASTM F-136 implant grade titanium alloy and ASTM 560 tantalum.

l. Performance Data Performance data is not provided in this submission.
The Substantial Equivalence Justification demonstrates that the J. Conclusion subject devices are as safe, as effective, and perform as well as the predicate devices.

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, indicating an affiliation with a public health organization.

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

June 13, 2014

Medos International. Sárl % Ms. Linda Bernier DePuy Synthes Spine, Incorporated 325 Paramount Drive Raynham, MA 02767

Re: K140759

K 140739
Trade/Device Name: Bengal System®, Bengal® Stackable System, Devex® System. Deligal System'S. Donge System, Concorde® (Bullet and Inline) Lumbar Interbody System, Cougar® System, Cougar® LS Lateral Cage System, Leopard® System

Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, MQP Dated: May 15, 2014 Received: May 16, 2014

Dear Ms. Bernier:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(t) promotion is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreasine) to regally many date of the Medical Device American program commerce provided thay 20, 1770. the encordance with the provisions of the Federal Food. Drug. devices mat have been reclassmed in acceraance . An accemarket 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 The general controls promotice, 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 mislcading.

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 is issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 fimited to: registration and listing (21

{12}------------------------------------------------

Page 2 - Ms. Linda Bernier

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 (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Ronald P. Jean -S for

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

Enclosure

{13}------------------------------------------------

Indications for Use

510(k) Number (if known)

K140759

Device Name

BENGAL® System. CONCORDE® Bullet Lumbar Interbody System. CONCORDE® Inline Lumbar Interbody System, COUGAR® System, DEVEX® System. LEOPARD® System

Indications for Use (Describe)

CONCORDE, COUGAR, DEVEX, and LEOPARD Systems Indications.

The CONCORDE. COUGAR, DEVEX, and LEOPARD Systems are intervertebral body fusion devices in skeletally mature patients with degenerative discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the (L2-SI). 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), TLIF (CONCORDE, DEVEX, LEÓPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices are intended for use with DePuy Spine supplemental internal fixation.

The CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are in the thoracolumbar spine (i.e., TI-LS) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anteriordecompression 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 biomechanial integrity of the anterior, middle and posterior spinal column even in the absence of fusion fora prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation.

BENGAL System Indications The BENGAL System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation should be used.

The BENGAL System is indicated for use in the thoracolumbar spine (i.e., TI-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. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is 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 this system is intended for use with DePuy Spine supplemental internal fixation.

AN AND OR COLLECTType of Use (Select one or both, as applicable)	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------			Comments of the first and the first and the first and the comments of
			11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11

. .

X Prescription Use (Part 21 CFR 801 Subpart D)

i_> Over-The-Counter Use (21 CFR 801 Subpart C)

{14}------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human SeNices Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor. and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{15}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K140759

Device Name

CONCORDE® Inline Lumbar Interbody System

Indications for Use (Describe)

Indications for Use (Describe)
The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVIX, and LEOPARD Systems are indicated The CONCORDE, CONCORDE Buile, CONCORDS Carrol vith degenerative disconcelive discopedia studies) on one of for use as interverted body itsion devices in skelcany matter part radiographic studies) at one of two discogenti back pan with degeneration of the dise committed of non-operative treatment prior to complois levels of the lumbal spine (22-31). I and more spine and are placed via either a PLIF (CONCORDE, surgery. These implans are used to acmare tusion in the balled, convel, DEVEX, LEONARD) or anterior CONCORDE Builet), TLIF (CONCORDE, CONCORDIT Builter, CONOCALD Gevices these implants are intended for use with DePuy Spine supplemental internal fixation products.

The CONCORDE, CONCORDE Builet, CONCORDE Curve, COUGAR,DEVEX, and LEDPARD Systems are indicated The CONCORDE, CONCORDE Buile, CONCORDE Care, CONOMICAL PLAY CHECHE OF CHE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE THE CELLED FOR for use in the thoracolumbas spine (t.e., 1 +1-3) is replace and to resore the height of a collepsed
of tumors, to achieve anterior decompression of the spiral conduction ins of tumors, to achieve anterior decompression of the not not nover of the shown is and umbar spine. These systems are
vertebral body. These systems are also indicated for midd vertebral body. These systems are also indicated to: middle and posted on spinal on umn even in the absence of designed to restore the biomethal integrity of the antenor, interest of these systems are intended for use with DePuy Spine supplemental internal fixation products.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

{16}------------------------------------------------

Indications for Use

510(k) Number (if known)

K140759

Device Name

COUGAR® LS Lateral Cage System

Indications for Use (Describe)

indcations on Use (Dostallo)
The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine((.c., T'I to LS) to replace a I he COOOH LES Datan Cago Dytern is merce the the treatment of tumors, to achieve anterior decompression of the spinal cord and neural issues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinst of the of seence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation.

The COUGAR LS Lateral Cage System is also indicated for intervertebral body fusion with and one grating to I he COUOAK LS Lateral Cage System is also muleated for meliguous levels from L2 to S1. These DDD patients may patients will degeneralive uiscase (DDD) at one onliness at the involved levels. DDD is defined as discogenic bask painter also have to the disc confirmed by history and radiographic studies. These patients should be skeletally mature with degentration of non-operative treatment. These implants may be implanted via an open or minimally a and have had six monits of low-operative firsting the resem is intended for use with DePuy Spine supplemental internal fixation.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Please do not write below this line - continue on a separate page if needed.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the semplate I he burden time for this collection of inistmation is econder and maintals the data needed and completer time to review the collections, Send comments regarding this burden estimate or any other aspect
and review the collection of information. Send comments regarding to tax and taview the collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

*An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{17}------------------------------------------------

Indications for Use

510(k) Number (if known) K140759

Device Name COUGAR® LS Lateral Cage System

Indications for Use (Describe)

indications for over is indicated for intervertebral body fusion with autogenous bone graft in patients with I he Lateral Cage Bysion is Interested in the release in the St. "These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with Orade 1 Spondytonshists of Ledonsmens at and involved with studies. These patients should be skeletally mature and degeneration of non-operative treatment. These implanted via an open or a minimally invasive have had six monula of not Ocage System is intended for use with DePuy Spine supplemental fixation.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the The burden time in this collection of information is osimilation is and mainting and completer aspect time to review the collection. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

EF PSC Publishing Services (701) 44) 474

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{18}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K140759

Device Name BENGAL® Stackable System

Indications for Use (Describe)

The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T i to L5) to replace a diseased percei THE VON System is 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.

The VBR Spinal Systems are also indicated for treating fractures of the thoracic and lumbar spine.

The VBR Spinal 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.

The VBR Spinal System is intended for use with supplemental internal fixation.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Please do not write below this line – continue on a separate page if needed.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the I he builden time for this collection of internation to oceasing the data needed and completer as any other spoct time to review institucions, Search existing detactived this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

: .

FORM FDA 3881 (1/14)

PSC Publishing Services (101) #43-6740 EP

{19}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Orug Administration

Indications for Use

510(k) Number (if known)

K140759

Device Name CONCORDE® Bullet Lumbar Interbody System

Indications for Use (Describe)

The Concorde VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-LS) to replace adiseased THE Occubrer TDA excised or excised for the treatment of tunors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.

The Concorde VBR Spinal System is designed to restore the biomcchanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The Concorde VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal I xation systems that may be used with the Concorde VBR Spinal System include DePuy Spine titanium plate or rod systems (j.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, T MX, MONARCH, Expedium, Viper, and Profile).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

PSC Publishing Services (301) 441-6720

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{20}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K140759

Device Name COUGAR® System

Indications for Use (Describe)

The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., TI to I.S) 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.

The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spinc.

The DoPuy AcroMed VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Sand comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PSC Publishing Services (101) 443-6740 187

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{21}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration .

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140759

Device Name DEVEX® System

Indications for Use (Doscribe)

The Devex Mcsh System is indicated for use in the thoracolumber spine (TI-I.S) 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.

The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Devex Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

HE PSL Publicions Rervices (101) 41) 4740

{22}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140759

Device Name

OCELOT® Stackable Cage System

Indications for Use (Describe)

The Stackable Cage System is indicated for use in the thoracolumbar spine (i.e., 'T to L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord neural tissues, and to restore the height of a collapsed vertebral body.

The Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine.

The Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

l_ | Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response. Including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Sand comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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.