(116 days)
No
The summary describes a physical implant (a vertebral body replacement cage) and its mechanical properties. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a vertebral body replacement system, which replaces a resected or excised vertebral body to restore spinal stability and function in cases of tumor or trauma/fracture, thereby treating a pathological condition.
No
The device is a vertebral body replacement system used to replace a resected or excised vertebral body, acting as an implant rather than a tool to diagnose conditions.
No
The device description clearly states it consists of physical implants made from PEEK or Titanium alloy, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device description: The Rectangular Corpectomy Cage is a physical implant designed to replace a vertebral body in the spine. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to replace a resected or excised vertebral body due to tumor or trauma/fracture. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant used for structural support and replacement within the body, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
MQP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (from T1 to L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Samson Corpectomy Cage (K091426), Synthes XRL System (K103320), PhenixTM VBR (K072029)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
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.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
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
1
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 (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/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)
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):
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Rectangular Corpectomy Cage
| Submitter: | Amendia, Inc.
1755 W. Oak Parkway
Marietta, GA 30062 |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Chelsea Proffitt
Regulatory Affairs Specialist
770-575-5181 (W), 877-420-1213 (F)
cproffitt@amendia.com (e-mail) |
| Date Prepared: | December 11, 2015 |
| Trade Name: | Rectangular Corpectomy Cage |
| Common Name: | Spinal intervertebral body fixation orthosis |
| Device Product Code and
Classification: | MQP, 888.3060, Class II, Spinal Vertebral Body Replacement
Device |
| Primary Predicate Device: | Samson Corpectomy Cage (K091426) |
| Additional Predicate Devices: | Synthes XRL System (K103320)
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.