(88 days)
Not Found
No
The document describes physical interbody fusion devices and their intended use, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The devices described (Spacers) are explicitly indicated as "integrated anterior lumbar interbody fusion devices" used to treat various medical conditions of the spine, such as degenerative disc disease and disc herniation, acting as an "adjunct to fusion." This falls directly under the definition of a therapeutic device which is intended to treat or alleviate a disease or condition.
No
The devices mentioned are interbody fusion devices, specifically spacers, used as an adjunct to fusion for treating various spinal conditions by providing structural stability. They are implantable therapeutic devices, not diagnostic ones designed to identify or analyze a medical condition.
No
The device description clearly indicates that these are physical implants (spacers, screws, anchors) used in spinal fusion surgery. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The text clearly describes the devices as "integrated anterior lumbar interbody fusion devices," "expandable anterior lumbar interbody fusion devices," and "lateral lumbar interbody fusion devices." Their intended use is to provide "structural stability" in the lumbosacral spine as an "adjunct to fusion" in patients with specific spinal conditions.
- Mechanism of Action: The devices are physical implants designed to be placed within the spine to facilitate bone fusion. They do not analyze biological samples.
The information provided focuses on the mechanical and structural function of the implants within the body, which is characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
INDEPENDENCE® Spacers (including INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™) are integrated anterior lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1) , as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 non-operative treatment. All INDEPENDENCE® TPS coated spacers are indicated for the same use as nor-coated PEEK versions.
INDEPENDENCE® Spacers are intended to be used with or without three screws which accompany the implants. INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™ Integrated Spacers are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 2, 2021
Globus Medical Inc. Kelly Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K203278
Trade/Device Name: INDEPENDENCE® Spacers, HEDRON IA™, MAGNIFY-S® Spacers, MONUMENT® Spacers, InterContinental® Plate-Spacer, ELSA® Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: November 4, 2020 Received: November 6, 2020
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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K203278
Device Name INDEPENDENCE® Spacers
Indications for Use (Describe)
INDEPENDENCE® Spacers (including INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™) are integrated anterior lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1) , as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 non-operative treatment. All INDEPENDENCE® TPS coated spacers are indicated for the same use as nor-coated PEEK versions.
INDEPENDENCE® Spacers are intended to be used with or without three screws which accompany the implants. INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™ Integrated Spacers are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Number (if known)
K203278
Device Name HEDRON IATM
Indications for Use (Describe)
HEDRON IA™ Integrated Lumbar Spacers are integrated lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 non-operative treatment. These devices are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
T
4
510(k) Number (if known)
K203278
Device Name MAGNIFY®-S Spacers
Indications for Use (Describe)
The MAGNIFY@-S Spacer is an interbody fusion device indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 at least six (6) months of non-operative treatment.
The MAGNIFY®-S Spacer is to be used with or without three screws which accompany the implant. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when used with three screws per implant. The MAGNIFY®-S Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| <img src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAABQSURBVDhPY6A8vXjxowIm4QOYiZmRkf8gkXH9+/f3DAwMDGjAwMD/gImYgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBgYGBG the following: Here's what I found: * Prescription Use (Part 21 CFR 801 Subpart D) is checked. * Over-The-Counter Use (21 CFR 801 Subpart C) is not checked. * The text |
time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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510(k) Number (if known)
K203278
Device Name MONUMENT® Spacers
Indications for Use (Describe)
The MONUMENT® Spacer is an interbody fusion device indicated for use at one or more levels of the lumbosacral spine (1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). 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.
The MONUMENT® Spacer is to be used with four screws that accompany the implant. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The MONUMENT® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of infornation is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known)
K203278
Device Name InterContinental® Plate-Spacer
Indications for Use (Describe)
InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 non-operative treatment. All InterContinental® TPS coated spacers are indicated for the same use as non-coated PEEK versions.
InterContinental® Plate-Spacers are intended to be used with or without two screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). InterContinental® Plate-Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
T
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510(k) Number (if known)
Device Name ELSA® Spacers
Indications for Use (Describe)
The ELSA® Spacer is an interbody fusion device indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 non-operative treatment.
The ELSA® Spacer is intended to be used with or without two screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two screws and/or anchors and supplemental fixation to the two screws and/or anchors. The ELSA®Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
8
510(k) Summary: INDEPENDENCE®, HEDRON IA™, MAGNIFY-S® MONUMENT®, InterContinental®, and ELSA® Additional Implants and Updated Indications
- Company: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 610-930-1800
- Contact: Kelly Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
Date Prepared: January 6, 2021
- INDEPENDENCE® Spacers Device Name: HEDRON IA™ MAGNIFY®-S Spacers MONUMENT® Spacers InterContinental® Plate-Spacer ELSA® Spacers
- Common Name: Intervertebral Body Fusion Device
Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Code(s): MAX, OVD Regulatory Class: II, Panel Code: 87
Primary Predicate: CORBEL™ Spacers (K201087)
Other Predicates: INDEPENDE® Spacers (K082252, K120101, K171848) INDEPENDENCE MIS® Spacers (K160597) INDEPENDENCE MIS AGX™ Spacers (K170157) HEDRON™ Lumbar Spacers (K191391) MAGNIFY®-S Spacers (K142498) MONUMENT® Spacers (K132559) InterContinental® Plate-Spacer (K103382, K161223, K171848) ELSA® Spacers (K161379) LDR Avenue-L Lateral Lumbar Cage (K153495) NuVasive Brigade Lateral System (K181386) NuVasive CoRoent XL (K201820)
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Purpose:
The purpose of this submission is to request clearance for new lateral anchors and cleared locking screws for use with ELSA® and InterContinental® spacers, and to indications for for INDEPENDENCE®, INDEPENDENCE update MIS®. apado - Indications - 181 - " INDEPENDE", " "ANDENEY®S, MONUMENT®, InterContinental®, and ELSA® spacers. Clearance is also requested for additional sterile implants and titanium plasma spray (TPS) coated spacers, and for MR Conditional labeling for the additional implants.
Device Description: INDEPENDENCE® Spacers
INDEPENDENCE® (including INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™) Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. 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. These devices may be used with screws and/or anchors.
HEDRON IA™
HEDRON IA™ Integrated Lumbar Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. These devices may be used with screws and/or anchors.
MAGNIFY®-S Spacers
MAGNIFY® Spacers are expandable anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The devices are available in various height expansion ranges 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. The MAGNIFY®-S Spacers are used with screws.
MONUMENT® Spacers
The MONUMENT® Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The MONUMENT® Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. 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.
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InterContinental® Plate-Spacer
InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. InterContinental® Plate-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 grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Bone screws and/or anchors may be used to attach to the lateral portion of the adjacent vertebral bodies for bony fixation.
ELSA® Spacers
ELSA® Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices 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. Bone screws and/or anchors may be used to the lateral portion of the adjacent vertebral bodies for bony fixation.
Indications for Use:
INDEPENDENCE® Spacers
(including INDEPENDENCE INDEPENDENCE® Spacers MIS® and INDEPENDENCE MIS AGX™) are integrated anterior lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 non-operative treatment. All INDEPENDENCE® TPS coated spacers are indicated for the same use as non-coated PEEK versions.
INDEPENDENCE® Spacers are intended to be used with or without three screws which accompany the implants. INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™ Integrated Spacers are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when