(49 days)
K 072465
K 072465
No
The description focuses on the mechanical properties and materials of a physical implant, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is intended to treat a pathological condition (collapsed, damaged, or unstable vertebral body due to tumor or trauma) and provide structural support, making it a therapeutic device.
No
The device is a vertebral body replacement device, which is an implant used for structural support following surgery, not for diagnosing medical conditions.
No
The device description clearly describes a physical implant made of PEEK and tantalum, intended for surgical implantation in the spine. It undergoes physical performance testing (compression, torsion, subsidence, expulsion). This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The VERTA Corpectomy Cage is a physical implant designed to replace a vertebral body in the spine. It is surgically implanted into the body.
- Intended Use: The intended use is to provide structural stability in the spine after a vertebral body is removed due to tumor or trauma. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The VERTA Corpectomy Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The device is intended for use with bone graft and with supplemental fixation systems (such as anterior plating systems, or posterior screw systems) cleared for use in the spine.
Product codes
MQP
Device Description
The VERTA Corpectomy Cage device is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following Corpectomy or vertebrectomy. The VERTA System is comprised of implants of various heights, to fit the needs of individual patient anatomy. Geometrically, the implants are designed as a load bearing frame with a hollow center which are applied to the spine to provide long-term structural support throughout fusion and to help enhance the fusion rate. Serrations on the superior and inferior surfaces of the device are designed to grip the endplates of the adjacent vertebrae to resist expulsion. The VERTA System implants are made from PEEK radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature individuals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Test Summary:
The following tests were performed to demonstrate that the VERTA Corpectomy Cage is substantially equivalent to other predicate device.
Static Compression Test per ASTM F2077
Dynamic Compression Test per ASTM F2077
Static Torsion Test per ASTM F2077
Dynamic Torsion Test per ASTM F2077
Subsidence Test per ASTM F2267
Expulsion Test
The results of these studies showed that the VERTA Cage met the acceptance criteria.
Clinical Test Summary:
No clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 072465
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
Camber Spine Technologies Mr. Daniel A. Pontecorvo President & CEO 418 East Lancaster Avenue Wayne, Pennsylvania 19087
Re: K143490
Trade/Device Name: VERTA Corpectomy Cage Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: December 8, 2014 Received: December 8, 2014
Dear Mr. Pontecorvo:
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
Page 2 - Mr. Daniel A. Pontecorvo
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143490
Device Name VERTA Corpectomy Cage
Indications for Use (Describe)
The VERTA Corpectomy Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-LS) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The device is intended for use with bone graft and with supplemental fixation systems (such as anterior plating systems, or posterior screw systems) cleared for use in the spine.
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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Image /page/3/Picture/0 description: The image contains the logo for Camber Spine Technologies. On the left is an orange square with rounded corners, inside of which is a white letter C. To the right of the square are the words "Camber Spine" in a larger, bold font, with the word "Technologies" underneath in a smaller font.
510(k) Summary Traditional 510k
as required by section 807.92(c).
VERTA Corpectomy Cage K143490 Prepared 1/20/15
| Submitter: | Camber Spine Technologies
418 E Lancaster Ave.
Wayne, PA 19087 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person | Dan Pontecorvo
President
Phone: 484-427-7060, Fax: (484) 318-8031
Email: dpontecorvo@cambermedtech.com |
| Trade Name | VERTA Corpectomy Cage |
| Common Name | Spinal Vertebral Body Replacement Device |
| Device Class | Class II |
| Classification Name
and Number | Spinal intervertebral body fixation orthosis,
21 CFR 888.3060 |
| Classification Panel: | Orthopedic |
| Product Code | MQP |
| Reason for 510k | New Device |
| Predicate Device | NIKO Corpectomy Spacer (K 072465) |
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| Device Description | The VERTA Corpectomy Cage device is a vertebral body replacement
device used to provide structural stability in skeletally mature
individuals following Corpectomy or vertebrectomy. The VERTA
System is comprised of implants of various heights, to fit the needs of
individual patient anatomy. Geometrically, the implants are designed
as a load bearing frame with a hollow center which are applied to the
spine to provide long-term structural support throughout fusion and
to help enhance the fusion rate. Serrations on the superior and
inferior surfaces of the device are designed to grip the endplates of
the adjacent vertebrae to resist expulsion. The VERTA System
implants are made from PEEK radiolucent material with embedded
tantalum x-ray markers as specified in ASTM F2026 and ASTM F560,
respectively. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The VERTA Corpectomy Cage is a vertebral body replacement device
intended for use in the thoracolumbar spine (T1-L5) to replace a
collapsed, damaged, or unstable vertebral body due to tumor or
trauma (i.e., fracture). The device is intended for use with bone graft and
with supplemental fixation systems (such as anterior plating systems, or
posterior screw systems) cleared for use in the spine. |
| Materials: | The implant is manufactured from Solvay Zeniva ZA-500 implant grade Polyetheretherketone (PEEK) (per ASTM2026).
The accessories are manufactured from 17-4 Stainless Steel (per ASTM F899-11) |
| ------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Statement of
Technological
Comparison | VERTA Corpectomy Cage and its predicate device have the same
indications for use, similar design, technical characteristics, and test
results. Both devices are manufactured using materials with a long
history of use in orthopedic implants. |
| --------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
5
| Nonclinical Test
Summary | The following tests were performed to demonstrate that the VERTA Corpectomy Cage is
substantially equivalent to other predicate device.
Static Compression Test per ASTM F2077 Dynamic Compression Test per ASTM F2077 Static Torsion Test per ASTM F2077 Dynamic Torsion Test per ASTM F2077 Subsidence Test per ASTM F2267 Expulsion Test The results of these studies showed that the VERTA Cage met the acceptance criteria. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test
Summary | No clinical tests were performed. |
| Sterilization Information | |
|---|---|
| Implants | The Implant will be shipped non-sterile and will be autoclaveable, validation testing of |
| the process was conducted (using the half-cycle method) to a Sterility Assurance Level | |
| (SAL) of $10^-6$ per ISO 17665. | |
| Instruments and | |
| Case | The instrument and case will be shipped non-sterile and will be autoclaveable, |
| validation testing of the process was conducted (using the half-cycle method) to a | |
| Sterility Assurance Level (SAL) of $10^-6$ per ISO 17665. |
| Conclusion | The VERTA Corpectomy Cage is substantially equivalent to its predicate device. This
conclusion is based upon the fact the VERTA Cage and its predicate device have the
same indications for use, have a similar design and technical characteristics, similar test
results, and any differences do not raise question of safety and effectiveness. |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|