(148 days)
Not Found
No
The summary describes a physical interbody fusion device made of titanium alloy, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to facilitate intervertebral body fusion in the cervical and lumbar spine to treat degenerative disc disease, which is a therapeutic purpose.
No
The device is an interbody fusion implant, meaning it is designed to facilitate the fusion of vertebrae in patients with degenerative disc disease. It is a therapeutic device, not one used for diagnosis.
No
The device description explicitly states that the system consists of "additively manufactured interbody cages, re-usable instruments and a sterilization tray," which are physical hardware components.
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 Description: The provided text clearly describes the Foundation 3D cervical and lumbar implants as interbody fusion devices made of titanium alloy. They are surgically implanted into the spine to facilitate bone fusion.
- Intended Use: The intended use is to treat degenerative disc disease by facilitating intervertebral body fusion. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Foundation 3D cervical implants are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
Foundation 3D lumbar implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Foundation implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Product codes
MAX
Device Description
The Foundation 3D Anterior Lumbar System is intended to be used as interbody fusion devices.
The Foundation 3D Anterior Lumbar System consists of additively manufactured interbody cages, re-usable instruments and a sterilization tray.
Foundation 3D Anterior Lumbar Cages are inserted between vertebral bodies in the anterior column of the lumbar spine. The new footprint / size cages are for this lumbar indication. The cages are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar line features a wide variety of lordosis and footprint options with fully porous architectures and varying pore sizes to offer increased room for bone growth with mechanical stability.
The Foundation 3D Anterior Lumbar System cages are made from the Titanium alloy Ti-6AL-4V ELI (conforming to ASTM F136 in terms of mechanical properties only) and are open in the center to accept autogenous bone graft material.
The new Anterior Lumbar Cages, which are the subject of this 510k, are in sizes: 25mm x 35mm, 25mm x 40mm, 27mm x 35mm, 27mm x 40mm, 30mm x 40mm, and 30mm x 45mm. Each footprint offers cage heights ranging from 10mm to 21mm in 1mm increments along with lordosis angles of 8° and 15°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1), lumbar spine (L2-S1)
Indicated Patient Age Range
skeletally mature patients
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)
Based on the risk analysis for the new implant sizes and deign verification testing conducted on the Foundation 3D Anterior Lumbar Cages, including Finite Element Analysis (FEA), it was determined that inclusion of these new sizes new worst-case test condition for mechanical testing, performance testing, sterilization, biocompatibility, shelf life, cleaning or packaging. Therefore, in accordance with the design control process, additional performance data was not necessary for the changes subject of this Special 510(k).
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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July 27, 2018
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and consists of a stylized caduceus. 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.
Corelink, LLC % Vikki M. O'Connor Regulatory Affairs Consultant Ambriel Associates, Inc. 411 Walnut St. Unit 9236 Green Cove Springs, Florida 32043
Re: K180556
Trade/Device Name: Corelink Foundation 3D Anterior Lumbar System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 8, 2018 Received: June 29, 2018
Dear Vikki M. O'Connor:
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180556
Device Name
Corelink Foundation 3D Anterior Lumbar System
Indications for Use (Describe)
Foundation 3D cervical implants are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
Foundation 3D lumbar implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Foundation implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
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) |
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510(k) Summary: Corelink Foundation 3D Anterior Lumbar System
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular, 21 CFR Part 807.92, the following summary of information is provided:
| Submitter: | Corelink, LLC
7911 Forsyth Blvd. Suite #200
St. Louis, MO 63105 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Vikki M. O'Connor
Regulatory Affairs Consultant
Phone: 1-207-214-8535
Email: vikki0730@yahoo.com |
| Date Prepared | June 8, 2018 |
| Trade Name | Corelink Foundation 3D Anterior Lumbar System |
| Proposed Class | Class II |
| Classification Name
and Number | Intervertebral Fusion Device with Bone Graft, Lumbar
888.3080 |
| Common Name | Interbody Fusion Device |
| Product Code / Panel | MAX / Orthopedics |
| Predicate Device | Corelink Foundation 3D Interbody ">– K162496 (Primary
Predicate), Corelink Foundation Lumbar Interbody
Devices - K150847 |
| Special Controls | N/A |
| Purpose of Submission | To add additional Anterior Lumbar Interbody Cage
footprints / sizes to the existing system. |
| Device Description | The Foundation 3D Anterior Lumbar System is intended
to be used as interbody fusion devices.
The Foundation 3D Anterior Lumbar System consists of
additively manufactured interbody cages, re-usable
instruments and a sterilization tray. |
| | Foundation 3D Anterior Lumbar Cages are inserted
between vertebral bodies in the anterior column of the
lumbar spine. The new footprint / size cages are for this
lumbar indication. The cages are designed to provide
mechanical support to the lumbar spine while arthrodesis
occurs. The lumbar line features a wide variety of lordosis
and footprint options with fully porous architectures and
varying pore sizes to offer increased room for bone
growth with mechanical stability.
The Foundation 3D Anterior Lumbar System cages are
made from the Titanium alloy Ti-6AL-4V ELI
(conforming to ASTM F136 in terms of mechanical
properties only) and are open in the center to accept
autogenous bone graft material.
The new Anterior Lumbar Cages, which are the subject of
this 510k, are in sizes: 25mm x 35mm, 25mm x 40mm,
27mm x 35mm, 27mm x 40mm, 30mm x 40mm, and
30mm x 45mm. Each footprint offers cage heights ranging
from 10mm to 21mm in 1mm increments along with
lordosis angles of 8° and 15°. |
| Indications for Use | The Foundation 3D cervical implants are indicated for use
in skeletally mature patients with degenerative disc
disease (DDD) of the cervical spine with accompanying
radicular symptoms at one disc level. DDD is defined as
discogenic pain with degeneration of the disc confirmed
by patient history and radiographic studies. Foundation
Cervical implants are used to facilitate intervertebral body
fusion in the cervical spine and are placed via an anterior
approach at one disc level (C2-T1) |
| | |
| | using autograft bone. Foundation 3D Interbody implants |
| | are to be used with supplemental fixation. Patients should |
| | have at least six (6) weeks of non-operative treatment |
| | prior to treatment with an intervertebral cage. |
| | The Foundation 3D lumbar implants are indicated for |
| | intervertebral body fusion procedures in skeletally mature |
| | patients with degenerative disc disease (DDD) of the |
| | lumbar spine at one or two contiguous levels from L2-S1. |
| | DDD is defined as discogenic pain with degeneration of |
| | the disc confirmed by history and radiographic studies. |
| | These DDD patients may also have up to Grade I |
| | spondylolisthesis or retrolisthesis at the involved level(s). |
| | Foundation implants are to be used with autogenous |
| | bone graft and supplemental fixation. Patients should |
| | have at least six (6) months of non- operative treatment |
| | prior to treatment with an intervertebral cage. |
| Summary of the
Technological
Characteristics | Foundation 3D Anterior Lumbar System cages possess
the same technological characteristics as the primary
predicate Foundation 3D Interbody Lumbar Cages
(K162496). These include: Indications for Use, Method of
manufacture, implant design, materials, method of
implantation, method of packaging and sterilization. The
new sizes do not add additional risks and do not
represent a new worst case. |
| Performance Data | Based on the risk analysis for the new implant sizes and
deign verification testing conducted on the Foundation 3D
Anterior Lumbar Cages, including Finite Element Analysis
(FEA), it was determined that inclusion of these new sizes |
| | new worst-case test condition for mechanical testing, |
| | performance testing, sterilization, biocompatibility, shelf |
| | life, cleaning or packaging. Therefore, in accordance with |
| | the design control process, additional performance data |
| | was not necessary for the changes subject of this |
| | Special 510(k). |
| Difference between | The only difference between the subject and predicate |
| Subject and Predicate | devices are the addition of new lumbar sizes. |
| Conclusion | Based on the indications for use, technological |
| | characteristics, materials, required performance testing, |
| | principles of operation, anatomical site, safety |
| | characteristics and comparison to the predicate device, |
| | Corelink's Foundation 3D Interbody Anterior Lumbar |
| | Cages have been shown to be substantially equivalent to |
| | the legally marketed predicate device. |
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