(137 days)
Not Found
No
The description focuses on the physical design, materials, and mechanical testing of an interbody fusion device. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "interbody fusion device intended for use in patients with degenerative disc disease (DDD)" and is used to "provide structural stability." This directly indicates a therapeutic purpose.
No
The device is described as an interbody fusion device intended for structural support and stability in spinal fusion, not for diagnosing medical conditions.
No
The device description clearly states it is an interbody fusion device made from PEEK polymer and titanium alloy, and includes screws for fixation. This indicates it is a physical implant, not a software-only device.
Based on the provided text, the MONUMENT™ Spacer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the MONUMENT™ Spacer clearly indicates it is an implantable medical device used in surgery to provide structural stability in the spine. It is a physical object inserted into the body, not a tool for analyzing biological samples.
The text describes a surgical implant for spinal fusion, not a diagnostic test performed on biological specimens.
N/A
Intended Use / Indications for Use
The MONUMENT™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back 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) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).
Product codes
OVD
Device Description
The MONUMENT™ Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The MONUMENT™ Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. The spacer is 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 bonv fixation. The spacer is to be filled with autogenous bone graft material.
The MONUMENT™ Spacer is made from radiolucent PEEK polymer and titanium alloy, as specified in ASTM F136, F1295, and F2026. The mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-S1)
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)
Mechanical testing (static and dynamic compression, static and dynamic compression shear, subsidence, and expulsion) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM 2267. Performance and comparative analysis data demonstrate that the different technological features do not affect the safety and effectiveness of the device and support substantial equivalence to the predicate devices.
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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K132559
DEC 3 0 2013 Page 1 of 2
510(k) SUMMARY: MONUMENT™ Spacer
- Company: Globus Medical Inc. 2560 General Armistead Avenue. Audubon, PA 19403 (610) 930-1800
- Contact: Christina Kichula Group Manager, Regulatory Affairs
- August 14, 2013 Date Prepared:
Device Name: MONUMENT ™ Spacers
- Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Code: OVD Regulatory Class: II, Panel Code: 87
- Globus Medical INDEPENDENCE® Spacer (K082252 & Predicate(s): K120101)
Purpose:
The purpose of this submission is to request clearance for MONUMENT™ Spacers.
Device Description:
The MONUMENT™ Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The MONUMENT™ Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. The spacer is 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 bonv fixation. The spacer is to be filled with autogenous bone graft material.
- The MONUMENT™ Spacer is made from radiolucent PEEK polymer and titanium alloy, as specified in ASTM F136, F1295, and F2026. The mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.
Indications for Use:
The MONUMENT™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These
1
K132559 Page 2 of 2
patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).
Performance Data:
Mechanical testing (static and dynamic compression, static and dynamic compression shear, subsidence, and expulsion) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM 2267. Performance and comparative analysis data demonstrate that the different technological features do not affect the safety and effectiveness of the device and support substantial equivalence to the predicate devices.
Basis for Substantial Equivalence:
MONUMENT™ Spacers have been found to be substantially equivalent to the predicate with respect to technical characteristics, performance, design, materials, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device. MONUMENT™ Spacers are as safe, as effective, and perform as well as or better than predicate devices.
2
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2013
Globus Medical, Incorporated Ms. Christina Kichula Group Manager, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K132559
Trade/Device Name: MONUMENT™ Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: December 4, 2013 Received: December 5, 2013
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 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 (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 (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 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" (21 CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K132559 Page 1 of 1
Indications for Use Statement
K132559 510(k) Number:
MONUMENT™ Spacers Device Name:
INDICATIONS:
・・・・
The MONUMENT™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back 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) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).
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)
David Hwang (dth.D. Division afformopedie Devices