(92 days)
Not Found
No
The document describes a mechanical fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for use in the treatment of various spinal instabilities, including fractures, tumors, degenerative disc disease, scoliosis, kyphosis, and spinal stenosis, and provides temporary stabilization and augmentation of spinal fusion, all of which are therapeutic actions.
No
The device is an anterior fixation system designed for temporary supplemental fixation and stabilization of the spine, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components like plates, cap screws, bone screws, and instrumentation, all manufactured from titanium alloy. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for stabilizing the spine in the treatment of various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like plates, screws, and instrumentation used for surgical implantation. This aligns with a surgical device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a surgical implant used in the body for structural support and stabilization.
N/A
Intended Use / Indications for Use
The V2F Anterior Fixation System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis or a failed previous spine surgery.
Product codes
KWQ
Device Description
The V2F Anterior Fixation System is a temporary supplemental fixation device consisting of: thoracolumbar plates, cap screws, bone screws and instrumentation necessary for implantation of the system.
The V2FTM Anterior Fixation System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anteriorlateral approach. All implant components are manufactured from titanium alloy as specified in ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and thoracolumbar (T1-L5) spine
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
ASTM F1717 static compression bending, static torsion and dynamic compression bending were performed to establish substantial equivalence. The test results demonstrate that the V2FM Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s).
Key Metrics
Not Found
Predicate Device(s)
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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K122733 Page 1 of 2
DEC 07 2012
510(k) Summary
Submitter:
Author:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name and Reference:
Predicate(s):
Zimmer Spine 5301 Riata Park Court, Bldg F Austin, TX 78727
Jennifer Tribbett Senior Regulatory Affairs Specialist
Jennifer Tribbett Senior Regulatory Affairs Specialist Telephone: (512) 533-1061 Fax: (512) 219-5463
September 5, 2012
V2FTM Anterior Fixation System
Spinal Fixation System
Orthosis, Spinal Intervertebral Fixation 21 CFR § 888.3060, KWQ, Class II
· InCompass Spinal Fixation System (K021564)
· Synthes Thoracolumbar Spine Locking Plate (TSLP) System (K020244)
Device Description:
The V2F™ Anterior Fixation System is a temporary supplemental fixation device consisting of: thoracolumbar plates, cap screws, bone screws and instrumentation necessary for implantation of the system.
The V2FTM Anterior Fixation System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anteriorlateral approach. All implant components are manufactured from titanium alloy as specified in ASTM F136.
1
17
Indications for Use:
The V2F™ Anterior Fixation System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis or a failed previous spine surgery.
Performance Data:
ASTM F1717 static compression bending, static torsion and dynamic compression bending were performed to establish substantial equivalence. The test results demonstrate that the V2FM Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s).
Basis of Substantial Equivalence:
The V2F™ Anterior Fixation System is similar to the predicate devices with respect to technical characteristics, design, materials, performance and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device(s).
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter dated: December 7, 2012
Zimmer Spine % Mr. Ron Yarbrough Director of Regulatory Affairs 5301 Riata Park Court, Building F Austin. Texas 78727
Re: K122733
Trade/Device Name: V2F™ Anterior Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: October 18, 2012 Received: October 24, 2012
Dear Mr. Yarbrough:
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
3
Page 2 - Mr. Ron Yarbrough
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopaedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: V2FTM Anterior Fixation System
Indications for Use:
The V2F™ Anterior Fixation System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis or a failed previous spine surgery.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Caroline Rhim -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122733