Bengal Stackable Cage System

K190284 · Medos International SARL · PLR · Dec 20, 2019 · Orthopedic

Device Facts

• Record ID: K190284
• Device Name: Bengal Stackable Cage System
• Applicant: Medos International SARL
• Product Code: PLR · Orthopedic
• Decision Date: Dec 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bengal® Stackable Cage 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 Bengal® Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Bengal® 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 Bengal® Stackable Cage System is intended for use with supplemental internal fixation. The Bengal® Stackable Cage System is also indicated for use in the cervical spine (C3-C7 vertebral bodies for the standard and large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The Bengal® Stackable Cage System for use in the cervical spine is designed to restore the integrity of spinal column even in the absence of fusion for a limited time period, in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with the surgeon's bone graft material of choice. The Bengal® Stackable Cage System is intended for use with supplemental internal fixation. When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA.

Device Story

The Bengal Stackable Cage System is a vertebral body replacement (VBR) device designed for spinal reconstruction. Implants are constructed from polymer/carbon-fiber composite with ridges/teeth to resist migration and rotation, and cavities for bone graft packing. The system is used by surgeons in clinical settings to restore spinal column biomechanical integrity following corpectomy or vertebral body resection due to tumor or trauma. It functions as a structural spacer to replace diseased or collapsed vertebrae and requires supplemental internal fixation. The device provides mechanical support to the anterior, middle, and posterior spinal columns, facilitating decompression of neural tissues. It is intended for use in patients with advanced tumors where fusion may not be achievable due to limited life expectancy, as well as for standard fracture treatment.

Clinical Evidence

No new clinical testing was performed. Evidence consists of a literature analysis of published clinical data for similar interbody fusion devices, which supports the safety and effectiveness of the subject device for the expanded cervical spine indication.

Technological Characteristics

Implants consist of PEEK Optima LT1DA30 polymer/carbon-fiber composite (ASTM F2026-12, USP Class VI, ISO 10993-1), tantalum markers (ASTM F560), and Ti-6Al-4V titanium alloy nuts/screws (ASTM F136). Accessories are stainless steel, silicone, and polypropylene (ASTM D4101). The system is a mechanical VBR implant; no software or energy source is involved.

Indications for Use

Indicated for skeletally mature patients requiring partial or total vertebral body replacement in the cervical (C3-C7), thoracic, or lumbar spine due to tumor, trauma (fracture), or collapse. Used for anterior decompression and height restoration. Contraindicated in patients without supplemental internal fixation; requires posterior fixation for >2 cervical levels.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Modulift Vertebral Body Replacement (VBR) System (K172032)
• Bengal Stackable Cage System (K073649)
• Bengal Stackable Cage System (K140759)

Submission Summary (Full Text)

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December 20, 2019

Medos International SARL % Karin McDonough Regulatory Affairs Specialist DePuy Synthes Spine 325 Paramount Drive Raynham, Massachusetts 02767

Re: K190284

Trade/Device Name: Bengal® Stackable Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR, MQP Dated: November 19, 2019 Received: November 20, 2019

Dear Karin McDonough:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brent L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K190284

Device Name Bengal® Stackable Cage System

### Indications for Use (Describe)

The Bengal® Stackable Cage 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 Bengal® Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Bengal® 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 Bengal® Stackable Cage System is intended for use with supplemental internal fixation.

The Bengal® Stackable Cage System is also indicated for use in the cervical spine (C3-C7 vertebral bodies for the standard and large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The Bengal® Stackable Cage System for use in the cervical spine is designed to restore the integrity of spinal column even in the absence of fusion for a limited time period, in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with the surgeon's bone graft material of choice. The Bengal® Stackable Cage System is intended for use with supplemental internal fixation. When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA.

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

| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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# 510(K) SUMMARY

#### A. Submitter Information

| 510(k) Sponsor: | DePuy Synthes Spine<br>325 Paramount Drive<br>Raynham, MA 02767 |
|-----------------|------------------------------------------------------------------------------------|
| Contact Person: | Karin McDonough<br>DePuy Synthes Spine<br>325 Paramount Drive<br>Raynham, MA 02767 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

#### B. Date Prepared December 20, 2019

#### C. Subject Device Name

| Trade/Proprietary Names: | Bengal® Stackable Cage System |
|--------------------------|---------------------------------------------------------------------------------|
| Common/Usual Names: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Names: | Class II<br>Spinal Intervertebral Body Fixation Orthosis<br>Per 21 CFR 888.3060 |
| Product codes: | <b>PLR, MQP</b> |

#### Primary Predicate Device Name D.

| Trade/Proprietary Names: | Modulift Vertebral Body Replacement (VBR) System<br>(K172032) |
|--------------------------|-----------------------------------------------------------------------------|
| Common/Usual Names: | Spinal Vertebral Body Replacement Device Cervical |
| Classification Names: | Class II<br>Spinal Intervertebral Body Fixation Orthosis<br>21 CFR 888.3060 |
| Product codes: | PLR |

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K190284 Page 2 of 4

#### E. Additional Predicate Device Name

| Trade/Proprietary Names: | Bengal Stackable Cage System (K073649, K140759) |
|--------------------------|-----------------------------------------------------------------------------|
| Common/Usual Names: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Names: | Intervertebral Fusion Device with Bone Graft,<br>Lumbar Per 21 CFR 888.3080 |
| Product codes: | MAX, MQP |

#### F. Submission Purpose

The purpose of this submission is to seek clearance to expand the indication for use for Bengal Stackable Cage System to include the cervical spine (C3-C7).

#### G. Device Description

The Bengal Stackable Cage System is a VBR Spinal System designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period, as well as for treating fractures of the thoracic and lumbar spine.

The structure of the polymer/carbon-fiber composite implants has been shown to support anticipated loads with a modulus of elasticity approximating that of cortical bone. The implants have ridges or teeth in both the anterior-posterior and medial-lateral directions, which resist rotation and migration. The polymer/carbon-fiber composite implants have cavities to accept packing of bone graft.

#### H. Indications for Use

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

The Bengal® 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 Bengal® Stackable Cage System is intended for use with supplemental internal fixation.

The Bengal® Stackable Cage System is also indicated for use in the cervical spine (C3-C7 vertebral bodies for the standard and large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral

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body due to tumor, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The Bengal® Stackable Cage System for use in the cervical spine is designed to restore the integrity of spinal column even in the absence of fusion for a limited time period, in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with the surgeon's bone graft material of choice.

The Bengal® Stackable Cage System is intended for use with supplemental internal fixation. When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA.

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

The technological characteristics of the subject Bengal Stackable Cage System remain unchanged from their currently marketed predicate version in their design, material, performance, and intended use.

#### J. Materials

The materials of the subject implants remain unchanged from that of the previously cleared implants.

The Bengal Stackable Cage System implants are made of a polymer/carbon-fiber The polymer/carbon-fiber composite is made from PEEK Optima composite. LT1DA30 which complies with ASTM F2026-12, USP Class VI and ISO 10993-1. The Bengal cages have a tantalum ball per ASTM-F560 and a nut component made from titanium alloy, same as the screws, Ti-6Al-4V per ASTM F136.

The accessories are all class I instruments made from stainless steel, silicone and polypropylene (or polyprolylux) a material that complies with ASTM D4101 for extruded polypropylene.

#### K. Performance Data

A literature analysis of published clinical data is provided to support the modified indication for use. The clinical outcomes demonstrate that interbody fusion devices similar to the subject devices are as safe and effective as the primary predicate devices and the additional predicate devices for the modification for use. No additional testing was required as the technological characteristics are consistent and or similar with those of the primary predicate device and the additional predicate device.

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#### L. Conclusion

The substantial equivalence justification provided in this submission demonstrates that device is equivalent to the safety and effectiveness of the predicate the subject devices. The intended use and technological characteristics are consistent and/or similar with those of both the primary predicate device and the additional predicate devices.