(92 days)
Not Found
No
The summary describes a mechanical implant system for spinal fixation and does not mention any AI or ML components.
Yes.
The device is intended for "anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease ..., trauma ..., tumors, deformity ..., pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis," all of which define conditions that would be treated by a therapeutic device.
No
Explanation: The device is an anterior cervical plate system intended for surgical fixation to the cervical spine, not for diagnosing medical conditions.
No
The device description clearly states it consists of plates and screws, which are physical hardware components intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior screw fixation to the cervical spine (C2-C7)" for various spinal conditions. This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details plates and screws made of titanium alloy that attach to the vertebral body. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The UNIFY® Dynamic Anterior Cervical Plate System and the ASSURE® Anterior Cervical Plate System are 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.
The ASSURE® Anterior Cervical Plate System is interior screw fixation to the cervicel spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with disc confirmed by patient history and radiographic studies), trauna (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions. spondylolisthesis, and spinal stenosis.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The UNIFY® Dynamic and ASSURE® Anterior Cervical Plate Systems consist of plates and variable or fixed angle screws. The plates attach to the anterior portion of the vertebral body of the cervical spine (C2-C7). The UNIFY® plates allow translation to accommodate bone graft resorption.
The UNIFY® additional implants are manufactured from titanium alloy, as specified in ASTM standards F136, F1295 and F1472.
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
Prescription Use
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 (engineering analysis and static cantilever bending and screw push-out) was conducted in accordance with 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 devices.
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.
UNIFY® Dynamic Anterior Cervical Plate System (K121049), ASSURE® Anterior Cervical Plate System (K040721)
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.
Not Found
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
510(k) Summary: UNIFY® Dynamic and ASSURE® Anterior Cervical Plate Systems
| Company: | Globus Medical Inc.
Valley Forge Business Center
2560 General Armistead Avenue
Audubon, PA 19403
(610) 930-1800 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Christina Kichula
Group Manager, Regulatory Affairs |
| Date Prepared: | November 19, 2013 |
| Device Name: | UNIFY® Dynamic Anterior Cervical Plate System
ASSURE® 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. |
| Predicate(s): | UNIFY® Dynamic Anterior Cervical Plate System (K121049)
ASSURE® Anterior Cervical Plate System (K040721) |
Purpose:
The purpose of this submission is to request clearance for additional UNIFY® screws to be used with ASSURE® and UNIFY® plates and use of ASSURE® rigid screws with the UNIFY® plate.
Device Description:
The UNIFY® Dynamic and ASSURE® Anterior Cervical Plate Systems consist of plates and variable or fixed angle screws. The plates attach to the anterior portion of the vertebral body of the cervical spine (C2-C7). The UNIFY® plates allow translation to accommodate bone graft resorption.
The UNIFY® additional implants are manufactured from titanium alloy, as specified in ASTM standards F136, F1295 and F1472.
Indications for Use:
The UNIFY® Dynamic Anterior Cervical Plate System and the ASSURE® Anterior Cervical Plate System are 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,
1
deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
Technological Characteristics:
The technological characteristics of the UNIFY® additional implants are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.
Performance Data:
Mechanical testing (engineering analysis and static cantilever bending and screw push-out) was conducted in accordance with 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 devices.
Basis of Substantial Equivalence:
UNIFY® additional implants are similar to the predicate devices with respect to technical characteristics, material, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. UNIFY® additional implants perform as well as or better than the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with outstretched wings, stylized with three thick lines forming the body and wings.
Public I lealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2014
Globus Medical, Incorporated Ms. Christina Kichula Group Manager, Regulatory Affairs 2560 General Armistead Ave. Audubon, PA 19403 US
Re: K133567
Trade/Device Name: UNIFY® Dynamic Anterior Cervical Plate System. ASSURE® 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: January 29, 2014 Received: January 30, 2014
Dear Ms. Kichula:
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 nanufacturing 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Christina Kichula
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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,
Vincență@evlin -5
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date. December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K133567
Device Name
UNIFY® Dynamic Anterior Cervical Plate System
Indications for Use (Describe)
The UNIFY® Dynamic Anterior Cervical Plate System is intended for anterior servical spine (C2-C7) for the follawing indications: degenerative disc disease tus discogenic origin with degeneration of the disc confirmed by natient history and rediographic studies), traumn (including fractures), tumors, deformity (kyphosis, lordosis or scollosis), pseudarthrosis. failed previous fusions. spondylolisthesis, and spinal stenosis.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY HILL BE REAL BE REAL POLICE .
Concurrence of Center for Devices and Radiological Health (CDRK) (Signature)
Image /page/4/Picture/15 description: The image shows the text "Anton E. Dmitriev, PhD" in bold, with a line underneath. Below this, the text "Division of Orthopedic Devices" is displayed in a larger, bold font. The text is arranged to convey a sense of professional or organizational information, possibly indicating a person's name, title, and the division they belong to.
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5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K133567
Device Name
ASSURE® Anterior Cervical Plate System
Indications for Use (Describe)
The ASSURE® Anterior Cervical Plate System is interior screw fixation to the cervicel spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with disc confirmed by patient history and radiographic studies), trauna (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions. spondylolisthesis, and spinal stenosis.
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)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Image /page/5/Picture/15 description: The image shows the text "Anton E. Dmitriev, PhD" in bold font with a line underneath. Below this text is the text "Division of Orthopedic Devices" in a smaller, non-bold font. The text is black against a white background.
FORM FDA 3881 (9/13)
- Portider: Son and hollid 14.14.14.14.12.180 FT