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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.

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.

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."

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The K7 Lumbar Spacers are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.

The K7 Lumbar Spacers are a collection of radiolucent interbody devices having variously shaped cross-sections. The superior and inferior surfaces are open with parallel serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

The provided text describes the K7 Lumbar Spacers, a medical device for intervertebral body fusion. The study presented focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than a clinical study evaluating the device's performance in a human population.

Therefore, many of the requested categories related to clinical performance metrics, ground truth establishment, expert involvement, and reader studies are not applicable or cannot be extracted from this document, as the FDA 510(k) submission for this device type typically relies on demonstrating engineering and material equivalence for clearance.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression (according to ASTM F2077)
• Dynamic Compression (according to ASTM F2077) | Performance shown to be substantially equivalent to predicate devices. |
  | Subsidence Properties:
• Evaluated according to ASTM F2267 | Performance shown to be substantially equivalent to predicate devices. |
  | Technological Characteristics:
• Intended Use
• Basic Design (hollow column)
• Material (PEEK polymer and tantalum)
• Sizes (widths, lengths, heights within predicate range) | Same as predicate devices. |

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. The mechanical testing was likely performed on a representative sample of K7 Lumbar Spacers of the "worst case" configuration. The specific number of units tested for static, dynamic compression, and subsidence is not provided.
• Data Provenance: The data is from mechanical testing of the device itself (K7 Lumbar Spacers) in a laboratory setting, not from human subjects. Therefore, country of origin or retrospective/prospective clinical data is not applicable.

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

• This is not applicable. The "ground truth" for this device's regulatory clearance is established by engineering standards (ASTM F2077, ASTM F2267) and comparison to predicate device characteristics, not by expert clinical consensus on a "test set" of patient data.

4. Adjudication Method for the Test Set

• This is not applicable, as there was no clinical "test set" involving human interpretation or adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a spinal implant, and its regulatory clearance here is based on mechanical performance and material equivalence, not on the interpretative performance of a diagnostic algorithm or image analysis by human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• No, a standalone study in the context of AI algorithm performance was not done. This device is a physical implant, not an AI algorithm.

7. Type of Ground Truth Used

• For the mechanical performance, the "ground truth" is defined by engineering standards (ASTM F2077 for compression, ASTM F2267 for subsidence) and the established performance/characteristics of legally marketed predicate devices. The goal was to demonstrate that the K7 Lumbar Spacers met or were equivalent to these benchmarks.

8. Sample Size for the Training Set

• This is not applicable. There is no "training set" in the context of machine learning or AI as this is a physical medical device.

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

• This is not applicable. See point 8.

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