(82 days)
Not Found
No
The summary describes a mechanical implant for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for anterior screw fixation to the cervical spine for various medical conditions like degenerative disc disease, trauma, tumors, and deformity, which are therapeutic interventions.
No
The device is an implantable system (plates and screws) for anterior screw fixation to the cervical spine, used in various spinal conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of "plates and variable or fixed angle screws" made from titanium alloy, which are physical hardware components intended for surgical implantation.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The UNIFY™ Dynamic Anterior Cervical Plate System is a surgical implant intended for anterior screw fixation to the cervical spine. It is a physical device used to stabilize the spine, not to perform tests on biological samples.
The information provided clearly describes a surgical implant used for structural support in the spine, which falls under the category of a surgical device or implant, not an IVD.
N/A
Intended Use / Indications for Use
The UNIFY™ Dynamic Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis or scollosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
Product codes
KWQ
Device Description
The UNIFY™ Dynamic Anterior Cervical Plate System consists of plates and variable or fixed angle screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7). The plate allows translation to accommodate bone graft resorption.
UNIFY™ Dynamic Anterior Cervical Plate System implants are manufactured from titanium alloy, as specified in ASTM standards F136 and F1295.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
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)
Mechanical testing (static and dynamic compression, static torsion, and static tension) was conducted in accordance with ASTM F1717 and, the "Guidance for Industry and FDA Staff Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ASSURE® Anterior Cervical Plate (K040721), PROVIDENCE® Anterior Cervical Plate (K070775), XTEND® Anterior Cervical Plate (K092146), Medtronic ATLANTIS® Anterior Cervical Plate (K063100), Synthes Vectra™ Anterior Cervical Plate (K051665)
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.
0
510(k) Summary: UNIFY™ Dynamic Anterior Cervical Plate System
Company: Globus Medical Inc. Valley Forge Business Center 2560 General Armistead Avenue Audubon, PA 19403 (610) 930-1800
Contact: Meriam Youssef Project Manager, Requlatory Affairs
Date Prepared: April 5, 2012
Device Name: UNIFY™ Dynamic Anterior Cervical Plate System
Classification: Per 21 CFR as follows: §888.3060: Spinal Intervertebral Body Fixation Orthosis Product Code: KWQ Regulatory Class: II, Panel Code: 87
- ASSURE® Anterior Cervical Plate (K040721) Predicate(s): PROVIDENCE® Anterior Cervical Plate (K070775) XTEND® Anterior Cervical Plate (K092146) Medtronic ATLANTIS® Anterior Cervical Plate (K063100) Synthes Vectra™ Anterior Cervical Plate (K051665)
Purpose:
The purpose of this submission is to request clearance for the UNIFY™ Dynamic Anterior Cervical Plate System, a modification of the cleared ASSURE® Anterior Cervical Plate System.
Device Description:
The UNIFY™ Dynamic Anterior Cervical Plate System consists of plates and variable or fixed angle screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7). The plate allows translation to accommodate bone graft resorption.
UNIFY™ Dynamic Anterior Cervical Plate System implants are manufactured from titanium alloy, as specified in ASTM standards F136 and F1295.
Indications for Use:
The UNIFY™ Dynamic Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
1
KI21049
trauma (including fractures), tumors, deformity (kyphosis or scollosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
Technological Characteristics:
The technological characteristics of the UNIFY™ Dynamic Anterior Cervical Plate System are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.
Performance Data:
Mechanical testing (static and dynamic compression, static torsion, and static tension) was conducted in accordance with ASTM F1717 and, the "Guidance for Industry and FDA Staff Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device.
Basis of Substantial Equivalence:
The UNIFY™ Dynamic Anterior Cervical Plate System has been found to be substantially equivalent to the predicates with respect to technical characteristics. performance, design, materials and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Globus Medical, Inc. % Ms. Meriam Youssef Project Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K121049
Trade/Device Name: UNIF Y Dynamic Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 31, 2012 Received: June 01, 2012
Dear Ms. Youssef:
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 vour 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
JUN 2 7 2012
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Page 2 - Ms. Meriam Youssef
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.fdagov/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,
for N. Mulle
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K12104.9
Indications for Use Statement
510(k) Number:
KI 21049
Device Name:
UNIFY™ Dynamic Anterior Cervical Plate System
INDICATIONS:
The UNIFY™ Dynamic Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
Prescription Use ਮ (Per 21 CFR §801.109) Over-The-Counter Use
(PLEASE DO NOT WRITE ON THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
KIZIOH 4
(Division Sign-Ori) (Division Sign-On)
Division of Surgical, Orthopedic, Wishon of State Devices
510(k) Number_