(288 days)
No
The summary describes a mechanical implant for spinal support and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a vertebral body replacement device intended to replace damaged or unstable vertebral bodies, providing support and stability for a prolonged period, which are therapeutic actions.
No
The device is a vertebral body replacement device, which is an implant used for structural support after a corpectomy or vertebrectomy, not for diagnosing conditions.
No
The device description clearly details physical components made of PEEK and titanium, which are hardware implants. The performance studies also focus on mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The VerteFIT™ Corpectomy Cage System is a physical implant designed to replace vertebral bodies in the spine. It is a surgical device used in vivo (within the body) to provide structural support.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes. Its function is purely mechanical and structural.
Therefore, the VerteFIT™ Corpectomy Cage System falls under the category of a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VerteFITTM Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFIT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFIT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
VerteFIT Corpectomy Cages are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include central PEEK cores and titanium-coated PEEK endcaps which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endcaps can be intraoperatively assembled to best fit patient anatomy requirements. Each endcap has a central axial chamber to allow autogenous bone graft or allograft to be packed inside of the spacer. Unidirectional teeth on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. VerteFIT endcaps (superior and inferior) have slots to accommodate VerteBRIDGE anchoring plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to 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)
Mechanical testing was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s., May 3, 2004" to demonstrate substantial equivalence to the predicate system(s). The following testing was done: Static & dynamic compression (ASTM F2077), Static & dynamic shear compression (ASTM F2077), Static & dynamic torsion (ASTM F2077), Subsidence (ASTM F2267), Cage and anchor expulsion (F-04.25.05.02), Corrosion testing (ASTM F2129). Clinical testing was not required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three human profiles facing right, layered on top of each other. The profiles are connected by flowing lines, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2017
LDR Spine USA, Inc. Bradley W. Strasser, RAC Project Manager, Regulatory Affairs 13785 Research Blvd, Suite 200 Austin, Texas 78750
Re: K162133
Trade/Device Name: VerteFIT™ Corpectomy Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: April 14, 2017 Received: April 17, 2017
Dear Mr. Strasser:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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,
Vincent J. Devlin -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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K162133 Page 1 of 1
Device Name VerteFITTM Corpectomy Cage System
Indications for Use (Describe)
The VerteFIT™ Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFTT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFTT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color, contrasting with the white background.
| 510(k) Summary | |
|---|---|
| Owner's Name & Address: | LDR Spine USA |
| 13785 Research Blvd. Suite 200 | |
| Austin, TX 78750 | |
| Contact Person: | Bradley W. Strasser, RAC |
| Project Manager, Regulatory Affairs | |
| Phone: (512) 344-3355 | |
| Fax: (512) 795-8306 | |
| Email: brad.strasser@zimmerbiomet.com | |
| Date: | February 15, 2017 |
| Trade Name: | VerteFITTM Corpectomy Cage System |
| Common Name: | Spinal Vertebral Body Replacement Device |
| Panel: | Orthopedic |
| Product Code: | MQP |
| Classification: | Class II (21 CFR 888.3060) |
| Predicate Devices: | Primary Predicate: |
| K2M Santorini Corpectomy Cage System (K111294, January 27, 2012) | |
| Secondary Predicate: | |
| Globus Medical FORTIFYTM I-R (K121107, July 3, 2012) | |
| Reference Predicate: | |
| LDR Spine ROI-C Titanium (K151934, December 7, 2015) | |
| Device Description | VerteFIT Corpectomy Cages are vertebral body replacement |
| devices used to provide structural stability in skeletally mature | |
| individuals following corpectomy or vertebrectomy. The | |
| components include central PEEK cores and titanium-coated | |
| PEEK endcaps which are available in a range of sizes and options | |
| to accommodate the anatomical needs of a wide variety of | |
| patients. The core and endcaps can be intraoperatively assembled | |
| to best fit patient anatomy requirements. Each endcap has a central | |
| axial chamber to allow autogenous bone graft or allograft to be | |
| packed inside of the spacer. Unidirectional teeth on the superior | |
| and inferior surfaces grip the endplates of the adjacent vertebrae | |
| to resist expulsion. VerteFIT endcaps (superior and inferior) have | |
| slots to accommodate VerteBRIDGE anchoring plates. |
4
Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.
| Indications for Use: | The VerteFIT TM Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFIT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFIT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). |
|---|---|
| Non-Clinical Performance Data: | Mechanical testing was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s., May 3, 2004" to demonstrate substantial equivalence to the predicate system(s). The following testing was done: Static & dynamic compression (ASTM F2077)Static & dynamic shear compression (ASTM F2077)Static & dynamic torsion (ASTM F2077)Subsidence (ASTM F2267)Cage and anchor expulsion (F-04.25.05.02)Corrosion testing (ASTM F2129) |
| Clinical Performance Data: | Clinical testing was not required to demonstrate substantial equivalence. |
| Basis of Substantial Equivalence: | The VerteFIT Corpectomy Cage System implants are similar to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device(s). |