(122 days)
No
The summary describes a mechanical implant and surgical instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a "Fixation Plate" intended for "supplemental fusion" to achieve "fixation/attachment" in the spine. These terms indicate a structural or supportive role rather than active therapy.
No
Explanation: The device is a fixation plate intended for supplemental fusion in the spine, which is a therapeutic rather than a diagnostic function. It is used to treat conditions, not to identify or diagnose them.
No
The device description explicitly states it is a "one-piece bilateral locking plate device" composed of "titanium 6AL-4V alloy," which are physical hardware components.
Based on the provided text, the VertiFlex® Spinous Process Fixation Plate is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The intended use and device description clearly state that the VertiFlex® Spinous Process Fixation Plate is an implantable device used for fixation in the spine. It is surgically implanted into the patient's body.
- The text describes a surgical implant. The device is a physical plate designed to be attached to spinous processes for supplemental fusion. This is a therapeutic device, not a diagnostic one.
Therefore, the VertiFlex® Spinous Process Fixation Plate falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VertiFlex® Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degenerationof the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The VertiFlex® Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.
Product codes
KWP
Device Description
The VertiFlex® Spinous Process Fixation (SPF) Plate is a one-piece bilateral locking plate device which attaches to the posterior non-cervical spine by securely grasping two adjacent spinous processes. The SPF Plate is available in multiple sizes to accommodate different anatomical requirements, and it is composed entirely of titanium 6AL-4V allov. The SPF Plate may be implanted by either conventional surgical methods, or via minimally-invasive techniques. Proprietary manual instrumentation for implantation of the SPF Plate is available for both conventional and minimally-invasive surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (non-cervical, T1-S1)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests conducted in accordance with such recognized standards as ASTM F1717-12, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, static pull-off testing in synthetic bone, and static dissociation testing, have demonstrated the substantial equivalence of the subject SPF Plate to a commerciallyavailable predicate in terms of performance. No clinical testing was conducted to support this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073278, K071877, K100935, K101471, K100354, K102195, K032037, K043053, K102866
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
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August 16, 2012
5.0 510(k) SUMMARY
In accordance with Title 21 Code of Federal Regulations (21 CFR), Part 807, and in particular, §807.92, the following 510(k) summary is provided for the VertiFlex® Spinous Process Fixation Plate:
Submitted By: 5.1
VertiFlex®, Incorporated 1351 Calle Avanzado San Clemente, California 92673
Contact: Steve Reitzler, Vice President, Clinical & Regulatory Affairs
Date Prepared: August 16, 2012
5.2 Device Name
| Trade or Proprietary Name: | VertiFlex® Spinous Process Fixation Plate |
|---|---|
| Common or Usual Name: | Spinous Process Fixation Plate |
| Classification Name: | Spinal Interlaminal Fixation Orthosis |
5.3 Predicate Devices
The subject device is substantially equivalent, in whole or in part, to the following commercially available predicate devices:
AffixTM Spinous Process Plate System (K073278; NuVasive, Inc.) Aspen™ Spinal Fixation System (K071877, K100935; Lanx, LLC) Axle™ Interspinous Fusion System (K101471; X-spine Systems, Inc.) PrimaLOK™ Interspinous Fusion System (K100354; OsteoMed Spine, Inc.) SP-Fix™ Spinous Process Fixation Plate (K102195; Globus Medical, Inc.) Spire™ Spinous Process Plate (K032037, K043053, K102866; Medtronic, Inc.)
Device Description 5.4
The VertiFlex® Spinous Process Fixation (SPF) Plate is a one-piece bilateral locking plate device which attaches to the posterior non-cervical spine by securely grasping two adjacent spinous processes. The SPF Plate is available in multiple sizes to accommodate different anatomical requirements, and it is composed entirely of titanium 6AL-4V allov. The SPF Plate may be implanted by either conventional surgical methods, or via minimally-invasive techniques. Proprietary manual instrumentation for implantation of the SPF Plate is available for both conventional and minimally-invasive surgical procedures.
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ર.5 Intended Use
The subject device is indicated for use as follows:
The VertiFlex® Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (TI - SI). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degenerationof the disc confirmed by history and radiographic studies); spondylolisthesis; Irauma (i.e., fracture or dislocation); and/or tumor. The VertiFlex® Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.
5.6 Comparison to Predicate Devices
Testing and comparisons of design characteristics and features have established that the subject SPF Plate is substantially equivalent in design, materials of composition, indications, performance, and other features, to other predicate spinous process fixation devices commercially available in the U.S.
5.7 Summary of Non-Clinical Tests
Non-clinical tests conducted in accordance with such recognized standards as ASTM F1717-12, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, static pull-off testing in synthetic bone, and static dissociation testing, have demonstrated the substantial equivalence of the subject SPF Plate to a commerciallyavailable predicate in terms of performance.
. 5.8 Summary of Clinical Tests
No clinical testing was conducted to support this submission.
રું તે તે જે જે જે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મ Conclusions
The results of all testing and comparison demonstrated the substantial equivalence of the subject SPF Plate to the identified predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002
December 17, 2012
VertiFlex®. Incorporated % Mr. Steve Reitzler · Vice President, Clinical & Regulatory Affairs 1351 Calle Avanzado San Clemente, California 92673
Re: K122509
Trade/Device Name: VertiFlex® Spinous Process Fixation Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 11, 2012 Received: December 12, 2012
Dear Mr. Reitzler:
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
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Page 2 - Mr. Steve Reitzler
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,
Image /page/3/Picture/6 description: The image shows the name "Erin FD Keith" in a stylized font. The first name, "Erin," is written in a bold, sans-serif font. The middle initials, "FD," are designed with a layered, geometric pattern. The last name, "Keith," is written in a similar style to the middle initials, with a layered effect.
Mark N. Meikerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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August 16, 2012
Indications for Use
510(k) Number (if known): _ K122509
VertiFlex® Spinous Process Fixation Plate Device Name:
Indications for Use:
The VertiFlex® Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degenerationof the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The VertiFlex® Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122509
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