(113 days)
No
The summary describes a suite of spinal fixation implants and their mechanical testing, with no mention of AI or ML technology.
Yes
The device is intended to treat acute and chronic instabilities or deformities in the spine, which is a therapeutic purpose.
No
The device is described as a "Spinal Fusion Platform" designed to stabilize the spine as an adjunct to fusion. It is a suite of fixation implants (screws, rods, locking caps) used for treatment/stabilization, not for diagnosing conditions.
No
The device description explicitly states it is comprised of "fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression," and lists components like "screws, rods and locking caps." This indicates a physical hardware device, not a software-only device. The performance studies also focus on mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for spinal fixation as an adjunct to fusion for various spinal conditions. This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as a suite of fixation implants (screws, rods, locking caps). These are physical components implanted into the spine.
- 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. This device does not perform such tests.
The information provided consistently points to a surgical implant, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:
- degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- spondylolisthesis;
- trauma (i.e., fracture or dislocation);
- spinal stenosis;
- curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor;
- pseudoarthrosis;
- and failed previous fusion.
Product codes
NKB, MNI, MNH
Device Description
The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression. The platform is comprised of screws. rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1-S1 vertebrae (non-cervical)
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
The CorticaLINK Spinal Fusion Platform has been tested in the following test modes:
- Static axial compression bending per ASTM F1717-14
- Dynamic axial compression bending fatigue per ASTM F1717-14
- Static torsion per ASTM F1717-14
- Static screw-shaft pull-through testing
- Static screw-shaft lever out testing
The results of this non-clinical testing show that the strength of the CorticaLINK Spinal Fusion Platform is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2016
FacetLINK dba LINKspine % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K160722
Trade/Device Name: CorticaLINK Spinal Fusion Platform Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: June 6, 2016 Received: June 9, 2016
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. Isting 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page. |
| ------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K160722 |
|---|---|
| Device Name | CorticaLINK Spinal Fusion Platform |
| Indications for Use (Describe) |
The CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an
adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1
vertebrae in skeletally mature patients:
- degenerative disc disease (defined as back pain of discogenic origin with degeneration
of the disc confirmed by history and radiographic studies); - spondylolisthesis;
- trauma (i.e., fracture or dislocation);
- spinal stenosis;
- curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor;
- pseudoarthrosis;
- and failed previous fusion.
| 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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
3
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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:
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"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."
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5.510(K) SUMMARY
| Submitter's Name: | FacetLINK dba LINKSpine |
|---|---|
| Submitter's Address: | 101 Roundhill Drive |
| Rockaway, NJ 07866 | |
| Submitter's Telephone: | 973.627.4171 |
| Contact Person: | Kenneth C. Maxwell II |
| Empirical Consulting | |
| 719.291.6874 | |
| Date Summary was Prepared: | 06 June 2016 |
| Trade or Proprietary Name: | CorticaLINK Spinal Fusion Platform |
| Common or Usual Name: | Orthosis, Spinal Pedicle Fixation |
| Orthosis, Spondylolisthesis Spinal Fixation | |
| Orthosis, Spinal Pedicle Fixation, For Degenerative Disc | |
| Disease | |
| Classification: | Class III |
| Product Code: | NKB, MNI, MNH |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression. The platform is comprised of screws. rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.
INDICATIONS FOR USE
The CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:
- degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- spondylolisthesis: ●
- trauma (i.e., fracture or dislocation); ●
- spinal stenosis;
- curvatures (i.e., scoliosis, kyphosis, and/or lordosis); ●
- tumor;
- pseudoarthrosis; ●
5
- and failed previous fusion. 0
The indications for use for the CorticaLINK Spinal Fusion Platform is similar to that of the predicate devices in Table 5-1.
TECHNOLOGICAL CHARACTERISTICS
The intended use and technological features of the CorticaLINK Spinal Fusion Platform do not substantially differ from the legally marketed predicate devices. The predicate devices and the CorticaLINK Spinal Fusion Platform are designed for posterior stabilization to provide immobilization and stabilization of spinal segments as an adjunct to fusion.
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate
Type |
|-------------|------------------------------------|-----------------|-------------------|
| K000236 | Synergy VLS Open | Interpore | Primary |
| K050979 | S4 Spinal System | Aesculap®, Inc. | Additional |
| K111940 | S 100 Pedicle Screw System | Renovis | Additional |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The CorticaLINK Spinal Fusion Platform has been tested in the following test modes:
- Static axial compression bending per ASTM F1717-14 ●
- Dynamic axial compression bending fatigue per ASTM F1717-14
- Static torsion per ASTM F1717-14 ●
- . Static screw-shaft pull-through testing
- . Static screw-shaft lever out testing
The results of this non-clinical testing show that the strength of the CorticaLINK Spinal Fusion Platform 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 CorticaLINK Spinal Fusion Platform is substantially equivalent to the predicate device.