(134 days)
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is an interbody fusion system used to treat Degenerative Disc Disease (DDD) at specific spinal levels, which involves addressing a medical condition and restoring function.
No.
The device is described as an interbody fusion system intended for surgical implantation in patients with Degenerative Disc Disease, not for diagnosing conditions.
No
The device description clearly states it consists of physical components like an interbody cage, locking plate, and bone screws, manufactured from titanium alloy. The performance studies also describe mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The CoreLink® M3™ Stand-Alone Anterior Lumbar System is a surgical implant (an interbody fusion system) used to treat Degenerative Disc Disease. It is physically implanted into the patient's spine.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens from the patient. While it uses patient history and radiographs for diagnosis, the device itself is a therapeutic implant, not a diagnostic tool that analyzes samples.
Therefore, the CoreLink® M3™ Stand-Alone Anterior Lumbar System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CoreLink® M3™ Stand-Alone Anterior Lumbar System is a standalone interbody fusion system indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The device may be used with supplemental fixation.
Hyperlordotic implants (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non- operative treatment prior to treatment with the devices.
The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, then additional supplemental fixation in the lumbar spine must be used to augment fixation.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The CoreLink® M3™ Stand-Alone Anterior Lumbar System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The CoreLink® M3TM Stand-Alone Anterior Lumbar System consists of an interbody cage, locking plate, and three (3) bone screws. System components are manufactured from either titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3 or additively manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F3001. The 8°, 15°, and 20° lordotic cages may be used as a standalone system. The M3 Stand-Alone Anterior Lumbar System M3 Stand-Alone Anterior Lumbar System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radios
Anatomical Site
L2-S1 (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 M3 Stand-Alone Anterior Lumbar System has been tested in the following test modes:
- Static axial compression per ASTM F2077-14
- Static compressive shear per ASTM F2077-14
- Static subsidence per ASTM F2267-04
- Static expulsion
- Dynamic axial compression per ASTM F2077-14
- Dynamic compressive shear per ASTM F2077-14
- Screw backout
- Wear debris analysis per ASTM F1877-16
The results of this non-clinical testing show that the strength of the M3 Stand-Alone Anterior Lumbar System 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.
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.
K111626, K142095, K150847, K162496
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
August 10, 2018
Image /page/0/Picture/1 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.
CoreLink, LLC % Meredith L. May Vice President Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K180814
Trade/Device Name: CoreLink® M3™ Stand-Alone Anterior Lumbar System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: July 5, 2018 Received: July 10, 2018
Dear Meredith L. May:
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
2
Indications for Use
510(k) Number (if known) K180814
Device Name
CoreLink® M3TM Stand-Alone Anterior Lumbar System
Indications for Use (Describe)
The CoreLink® M3™ Stand-Alone Anterior Lumbar System is a standalone interbody fusion system indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The device may be used with supplemental fixation.
Hyperlordotic implants (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non- operative treatment prior to treatment with the devices.
The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, then additional supplemental fixation in the lumbar spine must be used to augment fixation.
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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3
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: | Meredith L. May MS, RAC |
| Empirical Consulting | |
| 719.337.7579 | |
| Date Summary was Prepared: | 19-Mar-18 |
| Trade or Proprietary Name: | CoreLink® M3™ Stand-Alone Anterior Lumbar System |
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVD |
| Classification Panel: | Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The CoreLink® M3™ Stand-Alone Anterior Lumbar System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The CoreLink® M3TM Stand-Alone Anterior Lumbar System consists of an interbody cage, locking plate, and three (3) bone screws. System components are manufactured from either titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3 or additively manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F3001. The 8°, 15°, and 20° lordotic cages may be used as a standalone system. The M3 Stand-Alone Anterior Lumbar System M3 Stand-Alone Anterior Lumbar System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
INDICATIONS FOR USE
The CoreLink® M3™ Stand-Alone Anterior Lumbar System is a standalone interbody fusion system indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The device may be used with supplemental fixation.
Hyperlordotic implants (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
4
The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, then additional supplemental fixation in the lumbar spine must be used to augment fixation.
The indications for use for the CoreLink® M3™ Stand-Alone Anterior Lumbar System is similar to that of the NuVasive® ALIF Interfixated System.
TECHNOLOGICAL CHARACTERISTICS
Technical characteristics should include design, material, size, and shared similarities with predicate devices.
M3 Stand-Alone Anterior Lumbar System is made from material that conforms to ASTM F136 and ISO 5832-3. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- o Indications for Use
- Materials of manufacture ●
- Structural support mechanism ●
| 510k Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------|---------------|-------------------|
| K151214 | ALIF Interfixated System | NuVasive | Primary |
| K111626 | Endoskeleton TAS | Titan Spine | Additional |
| K142095 | Tesera SA ALIF Interbody System | Renovis Spine | Additional |
| K150847 | CoreLink Lateral | CoreLink | Additional |
| K162496 | Foundation™ 3D Interbody | CoreLink | Additional |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The M3 Stand-Alone Anterior Lumbar System has been tested in the following test modes:
- Static axial compression per ASTM F2077-14
- . Static compressive shear per ASTM F2077-14
- Static subsidence per ASTM F2267-04 ●
- Static expulsion o
- Dynamic axial compression per ASTM F2077-14 ●
- Dynamic compressive shear per ASTM F2077-14 ●
- Screw backout o
5
- . Wear debris analysis per ASTM F1877-16
The results of this non-clinical testing show that the strength of the M3 Stand-Alone Anterior Lumbar System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the CoreLink® M3™ Stand-Alone Anterior Lumbar System is substantially equivalent to the predicate device.