(129 days)
Not Found
No
The summary describes a physical implant (interbody fusion device) and its materials, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
The device is used to treat degenerative disc disease and provide structural stability following discectomy, indicating a therapeutic purpose.
No
The device is an interbody fusion device, specifically a cervical spacer, used to provide structural stability after discectomy. It is an implantable medical device, not a diagnostic tool that identifies or characterizes a disease or condition.
No
The device description clearly describes a physical implant made of polymer and titanium alloy, intended for surgical implantation. It is not a software-only device.
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 (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The COALITION™ Spacer is an implantable surgical device used to provide structural support and facilitate bone fusion in the cervical spine. It is physically inserted into the patient's body during surgery.
- Lack of Diagnostic Testing: The description clearly outlines its use as a structural implant for surgical treatment of degenerative disc disease. There is no mention of it being used to analyze samples or provide diagnostic information.
Therefore, based on the provided information, the COALITION™ Spacer is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The COALITION™ Spacer is a stand-alone interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. The COALITION™ Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.
Product codes
ODP, OVE
Device Description
The COALITION™ Spacer is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.
The COALITION™ Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, 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 (C3-T1)
Indicated Patient Age Range
skeletally mature
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)
The COALITION™ Spacer has been evaluated in accordance with the "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007 and have been found to meet the criteria set forth in the quidance document in terms of indications, design, and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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K083389 Page$\frac{1}{1}$
510(k) SUMMARY: COALITION™ SPACER
MAR 2 6 2009
-
Company: Globus Medical Inc. 2560 General Armistead Ave. Audubon. PA 19403 (610) 415-9000
Kelly J. Baker, Ph.D Contact: Director, Clinical Affairs & Regulatory -
Device Name: COALITION™ Spacer
Classification: Product Code ODP. Class II. 21 CFR §888.3080 Intervertebral body fusion device. -
PATRIOT™ Predicate(s): Cervical Spacer (Colonial™ ACDF Spacer) K072991 and other legally marketed devices.
Device Description:
The COALITION™ Spacer is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.
The COALITION™ Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.
Intended Use:
The COALITION™ Spacer is a stand-alone interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. The COALITION™ Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.
Basis for Substantial Equivalence:
The COALITION™ Spacer has been evaluated in accordance with the "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007 and have been found to meet the criteria set forth in the quidance document in terms of indications, design, and performance.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Globus Medical, Inc. % Kelly J. Baker, Ph.D. Director, Clinical Affairs & Regulatory 2560 General Armistead Avenue Audubon, Pennsylvania 19403
SEP 12 2011
Re: K083389
Trade/Device Name: COALITION™ Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: March 23, 2009 Received: March 24, 2009
Dear Dr. Baker:
This letter corrects our substantially equivalent letter of March 26, 2009.
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 (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.
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
2
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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark A. Milken
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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Indications for Use Statement
X083389 510(k) Number: Device Name: COALITION™ Spacer
Indications:
The COALITION™ Spacer is a stand-alone interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. The COALITION™ Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.
OR Prescription Use × (Per 21 CFR §801.109)
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)
D. Thm
Division Division of General, Restorative, and Neurological D
510(k) Number K68339