(239 days)
No
The summary describes a physical implant (interbody cage) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an interbody cage indicated for use in patients with degenerative disc disease to facilitate intervertebral body fusion, which directly addresses a medical condition and restores function, thus classifying it as therapeutic.
No
The device description clearly states its purpose is to provide mechanical support to the spine and facilitate intervertebral body fusion, not to diagnose a condition.
No
The device description clearly states it is an "additively manufactured implant comprising of cervical interbody spacers" and "lumbar interbody spacers," which are physical hardware components. The performance studies also describe testing of these physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Foundation™ 3D Interbody Cervical and Lumbar Cages are implants designed to be surgically placed in the spine to provide mechanical support and facilitate bone fusion. They are used in the body, not to test samples from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are typical of IVD devices.
Therefore, the Foundation™ 3D Interbody Cervical and Lumbar Cages are medical devices, specifically surgical implants, and not IVDs.
N/A
Intended Use / Indications for Use
The Foundation™ 3D Interbody Cervical Cage is 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 designed to be 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 Interbody Lumbar Cage is 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.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX
Device Description
The Foundation™ 3D Interbody Cervical Series Interbody System is an additively manufactured implant comprising of cervical interbody spacers. They are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The cervical line has a partially porous construction and an open architecture with a large variety of footprints and lordosis angles to help optimize implant fit.
The Foundation™ 3D Interbody Lumbar Series Interbody System is an additively manufactured implant comprising of lumbar interbody spacers. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar lines feature 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 series of intervertebral body fusion devices are made from the titanium alloy Ti-6AL-4V ELI conforming to the ASTM F-136 specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, lumbar spine
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)
The Foundation™ 3D Interbody has been tested in the following test modes:
- Static axial compression per ASTM F2077
- Static torsion per modified ASTM F2077
- Static compressive shear per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Dynamic torsion per ASTM F2077
- Dynamic compressive shear per ASTM F2077
- Subsidence per ASTM F2267
- Expulsion per ASTM F-04.25.02.02 DRAFT
The results of this non-clinical testing show that the strength of the Foundation™ 3D Interbody is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K150847, K073440, K151322, K120486
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K153250, K150765, K121103, K113559, K112095, K123281, K123752
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a head, body, and legs.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2017
CoreLink, LLC % Mr. Kenneth Maxwell Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K162496
Trade/Device Name: Foundation™ 3D Interbody Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: March 31, 2017 Received: April 3, 2017
Dear Mr. Maxwell:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
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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Indications for Use
510(k) Number (if known) K162496
Device Name Foundation™ 3D Interbody
Indications for Use (Describe)
The Foundation™ 3D Interbody Cervical Cage is 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 ior 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.
The Foundation™ 3D Interbody Lumbar Cage is 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 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
| Submitter's Name: | CoreLink, LLC |
|---|---|
| Submitter's Address: | 7911 Forsyth Blvd , Suite #200 |
| St. Louis, MO 63105 | |
| Submitter's Telephone: | 888.349-7808 |
| Contact Person: | Kenneth C. Maxwell II |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Date Summary was | |
| Prepared: | 31 March 2017 |
| Trade or Proprietary | |
| Name: | Foundation™ 3D Interbody |
| Common or Usual | |
| Name: | Intervertebral Fusion Device With Bone Graft, Cervical |
| Intervertebral Fusion Device With Bone Graft, Lumbar | |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | ODP, MAX |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Foundation™ 3D Interbody Cervical Series Interbody System is an additively manufactured implant comprising of cervical interbody spacers. They are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The cervical line has a partially porous construction and an open architecture with a large variety of footprints and lordosis angles to help optimize implant fit.
The Foundation™ 3D Interbody Lumbar Series Interbody System is an additively manufactured implant comprising of lumbar interbody spacers. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar lines feature 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 series of intervertebral body fusion devices are made from the titanium alloy Ti-6AL-4V ELI conforming to the ASTM F-136 specifications.
Indications for Use
The Foundation™ 3D Interbody Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radioular 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
4
are to be used with supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.
The Foundation™ 3D Interbody Lumbar Cage is 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 with an intervertebral cage.
The indications for use for the Foundation™ 3D Interbody is similar to that of the predicate devices listed in Table 5-1 below.
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K150847 | |||
| K073440 | Foundation™ Interbody System | CoreLink | Primary |
| K151322 | Interbody Fusion Device | Amendia | Additional |
| K120486 | AVS AS System | Striker Spine | Additional |
| K153250 | Tesera SC Stand-alone Anterior Cervical Fusion | ||
| (ACF) System | Renovis | Reference | |
| K150765 | |||
| K121103 | |||
| K113559 | ROI-C | LDR | Reference |
| K112095 | |||
| K123281 | |||
| K123752 | AccuLiF® TL-PEEK Cage and AccuLiF® TL and PL | CoAlign | |
| Innovation | Reference |
Table 5-1: Predicate Devices
PERFORMANCE DATA
The Foundation™ 3D Interbody has been tested in the following test modes:
- Static axial compression per ASTM F2077 ●
- Static torsion per modified ASTM F2077
- Static compressive shear per ASTM F2077 ●
- Dynamic axial compression per ASTM F2077 ●
- Dynamic torsion per ASTM F2077 ●
- Dynamic compressive shear per ASTM F2077 ●
- Subsidence per ASTM F2267 ●
- Expulsion per ASTM F-04.25.02.02 DRAFT ●
5
The results of this non-clinical testing show that the strength of the Foundation™ 3D Interbody is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
TECHNOLOGICAL CHARACTERISTICS
The following characteristics are similar between the subject and predicate devices:
- . Principles of Operations
- Indications for Use ●
- Materials ●
- Sterility o
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Foundation™ 3D Interbody is substantially equivalent to the predicate device.