(28 days)
Not Found
No
The 510(k) summary describes a system of mechanical implants (screws, rods, caps) for spinal fusion. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The description focuses on the materials, manufacturing, and intended use of the physical implants.
Yes
The device is intended for noncervical pedicle fixation as an adjunct to fusion for a variety of acute and chronic instabilities or deformities of the T1-S1 vertebrae, which clearly indicates its use in treating medical conditions.
No
The device is described as a "comprehensive suite of fixation implants" used to stabilize the spine as an adjunct to fusion. Its purpose is to physically treat instabilities or deformities, not to diagnose them.
No
The device description explicitly states it is comprised of physical components (screws, rods, locking caps) made of metal alloys, which are hardware, not software.
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 surgical implant system used to stabilize the spine as an adjunct to fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, and locking caps made of medical-grade materials. This aligns with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The CorticaLINK Fusion System is a physical implant used in surgery to treat spinal instabilities and deformities.
N/A
Intended Use / Indications for Use
The CorticaLINK Fusion System is intended for noncervical 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 (comma separated list FDA assigned to the subject device)
NKB
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.
The systems components are manufactured using standard manufacturing processes of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, Commercially Pure Grade4 Titanium (CP Ti) per ASTM F67 - Standard Specifications for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, R50400, R50500 & R50700) and Cobalt Chromium (CrCo) per ASTM F75 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075).
The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclave in accordance with the instructions for use provided by LinkSPINE, Inc., as well as the instructions provided by the Autoclave manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1-S1 vertebrae
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
healthcare professional
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)
LinkSPINE, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the CorticaLINK Spinal Fusion Platform modifications substantially meets the performance criteria established for the cleared parent device.
The modified device is used to treat the same indications for use, utilizes the same scientific and operational principles, and is manufactured using the same manufacturing practices from identical materials as the parent device.
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.
LinkSPINE, Inc. - CorticaLINK Spinal Fusion Platform (K160722)
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.
Not Found
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
§ 888.3070 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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. The words "U.S. Food & Drug Administration" are written in blue to the right of the square.
December 11, 2017
LinkSPINE, Inc. Mr. Nickolas G. Kriska Director of Engineering 5950 Symphony Woods Road, Suite 620 Columbia, Maryland 21044
Re: K173484
Trade/Device Name: CorticaLINK Spinal Fusion Platform Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: November 14, 2017 Received: November 15, 2017
Dear Mr. Kriska:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Ronald P. Jean -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)
K173484
Device Name CorticaLINK Spinal Fusion Platform
Indications for Use (Describe)
The CorticaLINK Fusion System is intended for noncervical 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | LinkSPINE, Inc.
(formerly known as FacetLINK Inc. dba Linkspine)
5950 Symphony Woods Rd.
Suite 620
Columbia, MD 21044
Telephone (410) 772-5465 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Nickolas G. Kriska
Director of Engineering |
| Date Prepared: | November 8, 2017 |
| DEVICE NAME | |
| Trade/Proprietary Name: | CorticaLINK Spinal Fusion Platform |
| Classification Panel: | Division of Orthopedic Devices |
| Common Name: | Thoracolumbosacral Pedicle Screw System |
| Classification: | Class II per 21 CFR §888.3070 |
|---|---|
| Product Code(s): | NKB |
ESTABLISHMENT REGISTRATION NUMBER
The LinkSPINE, Inc. (formerly known as FacetLINK Inc. dba Linkspine) establishment registration number is 3009442592.
INTENDED 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.
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
4
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.
The systems components are manufactured using standard manufacturing processes of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, Commercially Pure Grade4 Titanium (CP Ti) per ASTM F67 - Standard Specifications for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, R50400, R50500 & R50700) and Cobalt Chromium (CrCo) per ASTM F75 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075).
The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclave in accordance with the instructions for use provided by LinkSPINE, Inc., as well as the instructions provided by the Autoclave manufacturer.
EQUIVALENCE TO MARKETED PRODUCT
LinkSPINE, Inc. has submitted information to demonstrate that, for the purposes of FDA's requlation of medical devices, the CorticaLINK Spinal Fusion Platform is substantially equivalent to the predicate device based on a comparison including the following characteristics:
- FDA Product Code
- Intended Uses
- Anatomical Region
- Implant Materials
- Product Features
PRIMARY PREDICATE DEVICE
- . LinkSPINE, Inc. - CorticaLINK Spinal Fusion Platform (K160722)
PERFORMANCE COMPARISON
LinkSPINE, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the CorticaLINK Spinal Fusion Platform modifications substantially meets the performance criteria established for the cleared parent device.
The modified device is used to treat the same indications for use, utilizes the same scientific and operational principles, and is manufactured using the same manufacturing practices from identical materials as the parent device.