(226 days)
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No
The 510(k) summary describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are based on mechanical testing, not data analysis or image processing.
No.
The device, an Anterior Cervical Plate System, is intended for temporary stabilization and fixation of the cervical spine during fusions, which qualifies it as a surgical implant rather than a therapeutic device.
No
The device is an anterior cervical plate system intended for temporary stabilization and not for diagnosing medical conditions.
No
The device description explicitly states that the device is an "Anterior Cervical Plate System" and describes physical implants manufactured from Ti-6Al-4V ELI and nitinol. It also details performance studies involving mechanical testing of these physical components. This clearly indicates a hardware-based medical device, not a software-only one.
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. These tests are performed outside the body.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (an anterior cervical plate system) intended for anterior fixation of the cervical spine. This is a device that is surgically implanted inside the body to provide structural support.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test. Its function is purely mechanical and structural.
Therefore, based on the provided information, the CoreLink TERRACE™ Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CoreLink TERRACE™ Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 – T1.
Product codes
KWQ
Device Description
The Terrace™ Anterior Cervical Plate System is indicated for one through five levels of fixation and are provided in multiple sizes to accommodate a variety of patient anatomies. Screws are provided in multiple sizes to accommodate a variety of patient anatomies. Implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and nitinol conforming to ASTM F2063. Implants are provided non-sterile with instructions for sterilization.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine, C2 - T1
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The Terrace™ Anterior Cervical Plate System has been tested in the following test modes:
- Static axial compression bending per ASTM F1717-14 .
- Static torsion per ASTM F1717-14 ●
- Dynamic axial compression bending fatigue per ASTM F1717-14 ●
- . Corrosion testing per ASTM F2129
The results of this non-clinical testing show that the strength of the Terrace™ Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
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Predicate Device(s)
K121514, K102820, K100614, K130202, K133475
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2017
CoreLink, LLC % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs. Colorado 80918
Re: K163104
Trade/Device Name: Terrace™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 12, 2017 Received: June 13, 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) K163104
Device Name
Terrace™ Anterior Cervical Plate System
Indications for Use (Describe)
The CoreLink TERRACE™ Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 – T1.
| 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)
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| 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: | 20 June 2017 |
| Trade or Proprietary Name: | Terrace™ Anterior Cervical Plate System |
| Common or Usual Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification: | Class II per 21 CFR §888.3060 Device Classification |
| Product Code: | KWQ |
| Classification Panel: | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Terrace™ Anterior Cervical Plate System is indicated for one through five levels of fixation and are provided in multiple sizes to accommodate a variety of patient anatomies. Screws are provided in multiple sizes to accommodate a variety of patient anatomies. Implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and nitinol conforming to ASTM F2063. Implants are provided non-sterile with instructions for sterilization.
INDICATIONS FOR USE
The CoreLink TERRACE™ Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.
The indications for use for the Terrace™ Anterior Cervical Plate System is similar to that of the predicate devices noted in Table 5-1.
| 510k | Trade or Proprietary or Model | Manufacturer | Predicate |
|---|---|---|---|
| Number | Name | Type | |
| K121514 | ANODYNE® ACP System | CoreLink, LLC | Primary |
| K102820 | Trestle Luxe ACP | Alphatec | Additional |
| K100614 | Anterior Cervical Plating System | Orthofix | Additional |
| K130202 | IRIS™ ACP | Life Spine | Additional |
| K133475 | Struxxure | Next Spine | Additional |
Table 5-1 Predicate Devices
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PERFORMANCE DATA
The Terrace™ Anterior Cervical Plate System has been tested in the following test modes:
- Static axial compression bending per ASTM F1717-14 .
- Static torsion per ASTM F1717-14 ●
- Dynamic axial compression bending fatigue per ASTM F1717-14 ●
- . Corrosion testing per ASTM F2129
The results of this non-clinical testing show that the strength of the Terrace™ Anterior Cervical Plate System 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
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Terrace™ Anterior Cervical Plate System is substantially equivalent to the predicate device.