Rectangular Corpectomy Cage

K152460 · Amendia, Inc. · MQP · Dec 22, 2015 · Orthopedic

Device Facts

• Record ID: K152460
• Device Name: Rectangular Corpectomy Cage
• Applicant: Amendia, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Dec 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rectangular Corpectomy Cage is a vertebral body replacement system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Rectangular Corpectomy Cage is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.

Device Story

Rectangular Corpectomy Cage; vertebral body replacement system for thoracolumbar spine (T1-L5). Used in vertebrectomy procedures to replace collapsed/damaged/unstable vertebral bodies due to tumor or trauma. Implants feature hollow centers for autograft/allograft packing; superior/inferior surface ridges for endplate grip/expulsion prevention. Available in various sizes/shapes for anterior, anterolateral, lateral, and posterolateral surgical approaches. Used in conjunction with supplemental spinal fixation instrumentation. Surgeon-operated in clinical/OR settings. Provides structural support to spinal column; facilitates fusion via graft containment.

Clinical Evidence

Bench testing only. Performance testing included static and dynamic compression, static and dynamic torsion, and expulsion testing conducted per ASTM F2077 on worst-case configurations. No clinical data presented.

Technological Characteristics

Materials: PEEK (ASTM F2026) with tantalum (ASTM F560) markers or Titanium alloy (Ti6Al4V ELI, ASTM F136). Design: Hollow cage with surface ridges for endplate fixation. Dimensions: Various sizes/shapes for thoracolumbar application. Energy source: None (mechanical). Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) following resection or excision due to tumor or trauma/fracture. Must be used with supplemental fixation and autograft/allograft.

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

• Samson Corpectomy Cage (K091426)
• Synthes XRL System (K103320)
• Phenix™ VBR (K072029)

Submission Summary (Full Text)

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

December 22, 2015

Amendia, Incorporated Ms. Chelsea Proffitt Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062

Re: K152460

Trade/Device Name: Rectangular Corpectomy Cage Regulation Number: 21 CFR 888.3060 Regulation Name: Spine intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 22, 2015 Received: September 23, 2015

Dear Ms. Proffitt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Casey Hanley -S

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

Enclosure

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## Indications for Use

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

510(k) Number (if known)

K152460

Device Name Rectangular Corpectomy Cage

Indications for Use (Describe)

The Rectangular Corpectomy Cage is a vertebral body replacement system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Rectangular Cage is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft.

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

| <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) Summary

#### Rectangular Corpectomy Cage

| Submitter: | Amendia, Inc.<br>1755 W. Oak Parkway<br>Marietta, GA 30062 |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Chelsea Proffitt<br>Regulatory Affairs Specialist<br>770-575-5181 (W), 877-420-1213 (F)<br>[e-mail] (e-mail) |
| Date Prepared: | December 11, 2015 |
| Trade Name: | Rectangular Corpectomy Cage |
| Common Name: | Spinal intervertebral body fixation orthosis |
| Device Product Code and<br>Classification: | MQP, 888.3060, Class II, Spinal Vertebral Body Replacement<br>Device |
| Primary Predicate Device: | Samson Corpectomy Cage (K091426) |
| Additional Predicate Devices: | Synthes XRL System (K103320)<br>Phenix™ VBR (K072029) |

Purpose of Submission: This traditional 510(k) is seeking clearance for modifications to the Samson Corpectomy Cage, including modifications to the shape, to add Ti6Al4V ELI implant configurations in addition to two PEEK materials (Invibio Optima LT1 and Solvay Zeniva ZA-500) and an addition of dimensions.

#### Device Description:

The Rectangular Corpectomy Cage consists of multiple components comprised of sterile, single-use implants fabricated from PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Rectangular Corpectomy Cage is used to replace a collapsed, damaged or unstable vertebral body resected or excised during total and partial vertebrectorny procedures due to tumor or trauma. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The Rectangular Corpectomy Cage is comprised of implants designed to treat the thoracolumbar spine. The implants are available in a range of sizes and shapes to accommodate anterior. anterolateral, lateral and posterolateral surgical approaches and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

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#### Indications and Intended use:

The Rectanqular Corpectomy Cage is a vertebral body replacement system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Rectangular Corpectomy Cage is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.

### Summary of Technological Characteristics:

The subject Rectangular Corpectomy Cage is substantially equivalent to predicate devices cleared for commercial distribution in the United States. The Subject Device was shown to have the same technological characteristics as its predicate devices through comparison of characteristics including design, intended use, material composition, and function. Both the subject and predicate devices are vertebral body replacement devices designed to contain graft material and replace a collapsed, damaged or unstable vertebral body resected or excised during total and partial vertebrectomy procedures due to tumor or trauma in the thoracolumbar region of the spine.

### Summary of Performance Testing:

The substantial equivalence of the Rectangular Corpectomy Cage to the predicate is shown by similarity in intended use, indications for use, materials and performance. Non-clinical mechanical testing for the Rectangular Corpectomy Cage system was performed on the worst case subject device. Performance testing included static and dynamic compression (per ASTM F2077), static and dynamic torsion (per ASTM F2077) and expulsion testing. Design verification demonstrated the Subject Device is substantially equivalent to the predicate device.

#### Conclusion:

Based on the comparison to predicate devices and performance testing. the Rectangular Corpectomy Cage has been shown to be substantially equivalent to legally marketed predicate devices.