(124 days)
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related computational techniques.
Yes
The device is used for anterior screw fixation to the cervical spine for various medical conditions, including degenerative disc disease, trauma, tumors, and deformity, which are all therapeutic indications.
No
The XTEND™ Anterior Cervical Plate System is an orthopedic implant for stabilizing the cervical spine, not for diagnosing medical conditions.
No
The device description clearly states that the XTEND™ Anterior Cervical Plate System consists of physical components (plates and screws) made of titanium alloy, which are implanted into the cervical spine. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The XTEND™ Anterior Cervical Plate System is a surgical implant designed for fixation of the cervical spine. It is a physical device implanted into the body.
- Intended Use: The intended use clearly states it's for "anterior screw fixation to the cervical spine." This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The information provided describes a surgical implant used to stabilize the spine, which falls under the category of a surgical device or implant, not an IVD.
N/A
Intended Use / Indications for Use
The XTEND™ 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 (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Product codes
KWQ, KWO
Device Description
The XTEND™ Anterior Cervical Plate System consists of standard plates, Extender plates and Universal Extender plates. Extender plates may be used for revision surgery in which additional stabilization is required. Extender plates are attached to an adjacent XTEND™ plate, and Universal Extender plates are inserted adjacent to other plates. XTEND™ plates are available in various lengths to be used with either variable angle screws or fixed angle screws. Each XTEND™ plate is attached to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The XTEND™ Anterior Cervical Plate System implants are composed of titanium allov, as specified in ASTM 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
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.
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.
0
NOV 1 6 2009
510(K) Summary: XTEND™ Anterior Cervical Plate System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
(610) 415-9000 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D
Director, Clinical Affairs & Regulatory |
| Device Name: | XTEND™ 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): | VIP® K081391 (SE date July 3, 2008)
ASSURE® K040721 (SE date June 17, 2004)
PROVIDENCE® K070775 (SE date April 19, 2007) |
Device Description:
The XTEND™ Anterior Cervical Plate System consists of standard plates, Extender plates and Universal Extender plates. Extender plates may be used for revision surgery in which additional stabilization is required. Extender plates are attached to an adjacent XTEND™ plate, and Universal Extender plates are inserted adjacent to other plates. XTEND™ plates are available in various lengths to be used with either variable angle screws or fixed angle screws. Each XTEND™ plate is attached to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The XTEND™ Anterior Cervical Plate System implants are composed of titanium allov, as specified in ASTM F136 and F1295.
Intended Use:
The XTEND™ 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 (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Basis of Substantial Equivalence:
XTEND™ Anterior Cervical Plate System is similar to the predicate systems with respect to technical characteristics, performance, and intended use. Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.
1
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Globus Medical. Inc. % Kelly J. Baker, Ph.D. 2560 General Armistead Avenue, Valley Forge Audubon, Pennsylvania 19403
NOV 1 6 2009
Re: K092146
Trade/Device Name: XTEND Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: November 10, 2009 Received: November 12, 2009
Dear Dr. Baker:
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 incications 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 Foond, Or to 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 misburoni, in and adulteration.
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 dovine 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 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.
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Page 2 - Kelly J. Baker. Ph.D.
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 fou 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely vours.
Mark A. Millmann
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
Kog 2146 510(k) Number:
XTEND™ Anterior Cervical Plate System Device Name:
INDICATIONS:
The XTEND™ 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 (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Prescription Use × (Per 21 CFR §801.109) OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliken
(Division Sign-Off) (Division Sign-gical, Orthopedic, and Restorative Devices
510(k) Number K092144