(27 days)
Not Found
No
The device description and intended use clearly define the system as a mechanical implant for spinal fixation, consisting of screws, rods, hooks, plates, and connectors. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies mentioned are mechanical testing, further supporting the nature of the device as a physical implant.
Yes
The device is described as an "implant system used to provide temporary immobilization and stabilization of the cervical spine and occipito-cervicothoracic junction while fusion occurs," which directly addresses treating medical conditions.
No
The device is described as an "implant system used to provide temporary immobilization and stabilization of the cervical spine and occipito-cervicothoracic junction while fusion occurs." Its intended use is to provide stabilization, not to diagnose a condition.
No
The device description explicitly states it is an "implant system" consisting of physical components like screws, rods, hooks, plates, and connectors made from titanium and cobalt chromium alloys. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description clearly states that the Tiger Occipital-Cervical-Thoracic Spinal Fixation System is an implant system used to provide immobilization and stabilization of spinal segments. It is a physical device implanted into the body to support the spine.
- Lack of Biological Sample Testing: There is no mention of the device being used to test biological samples or provide diagnostic information based on such testing.
Therefore, the Tiger Occipital-Cervical-Thoracic Spinal Fixation 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 Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations: instability of deformity: failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Tiger Occipital-Cervical-Thoracic Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Tiger Occipital-Cervical-Thoracic Spinal Fixation System may be connected to the components in the Tiger Spine System using the side by side and end to end rod to rod connectors.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is an implant system used to provide temporary immobilization and stabilization of the cervical spine and occipito-cervicothoracic junction while fusion occurs. The Tiger Occipital-Cervical-Thoracic Spinal Fixation System consists of screws, rods, hooks, plates, and connectors in various configurations which can be assembled to create a construct that meets the need of the patient. It can be used for single or multiple level fixation. Spinal rods and hooks may be contoured intraoperatively to meet specific anatomical requirements.
Implants in the Tiger® Occipital-Cervical-Thoracic Spinal Fixation System are manufactured from titanium alloy Ti-6Al-4V per ASTM F136 and cobalt chromium alloy Co-28Cr-6Mo per ASTM F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3
Indicated Patient Age Range
Not Found
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)
In support of this Special 510(k) Device Modification Premarket Notification, mechanical testing was not required because the worst case components were previously tested under the clearance for K132504.
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.
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & 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, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2020
CoreLink, LLC % Mr. Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K200863
Trade/Device Name: Tiger® Occipital-Cervical-Thoracic Spinal Fixation System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: March 31, 2020 Received: April 1, 2020
Dear Mr. Wright:
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'Neill, MBE Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known) K200863
Device Name
Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
Indications for Use (Describe)
The Tiger Occipital-Cervical-Thoracic Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations: instability of deformity: failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Tiger Occipital-Cervical-Thoracic Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Tiger Occipital-Cervical-Thoracic Spinal Fixation System may be connected to the components in the Tiger Spine System using the side by side and end to end rod to rod connectors.
| 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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| Submitter's Name: | CoreLink, LLC |
|---|---|
| Submitter's Address: | 2072 Fenton Logistics Blvd |
| St. Louis, MO 63026 | |
| Submitter's Telephone: | 888-349-7808 |
| Contact Person: | Nathan Wright |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | 31-Mar-2020 |
| Trade or Proprietary Name: | Tiger® Occipital-Cervical-Thoracic Spinal Fixation |
| System | |
| Common or Usual Name: | OCT System |
| Classification: | Class II per 21 CFR 888.3075 and 21 CFR 888.3050 |
| Product Code: | NKG, KWP |
| Classification Panel: | Division of Orthopedic Devices |
5.510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is an implant system used to provide temporary immobilization and stabilization of the cervical spine and occipito-cervicothoracic junction while fusion occurs. The Tiger Occipital-Cervical-Thoracic Spinal Fixation System consists of screws, rods, hooks, plates, and connectors in various configurations which can be assembled to create a construct that meets the need of the patient. It can be used for single or multiple level fixation. Spinal rods and hooks may be contoured intraoperatively to meet specific anatomical requirements.
Implants in the Tiger® Occipital-Cervical-Thoracic Spinal Fixation System are manufactured from titanium alloy Ti-6Al-4V per ASTM F136 and cobalt chromium alloy Co-28Cr-6Mo per ASTM F1537.
INDICATIONS FOR USE
"The Tiger Occipital-Cervical-Thoracic Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Tiger Occipital-Cervical-Thoracic Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
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In order to achieve additional levels of fixation, the Tiger Occipital-Cervical-Thoracic Spinal Fixation System may be connected to the components in the Tiger Spine System using the side by side and end to end rod to rod connectors."
The indications for use for the Tiger® Occipital-Cervical-Thoracic Spinal Fixation System are similar to those of the predicates.
TECHNICAL CHARACTERISTICS
The Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is made from Ti-6A1-4V that conforms to ASTM F136 and Co-28Cr-6Mo that conforms to ASTM F1537. 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 similar between the subject and predicates:
- Indications for use ●
- Technological characteristics
- Materials of manufacture ●
- Structural support mechanism ●
- . Sizes
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K132504 | Tiger® Occipital-Cervical- | ||
| Thoracic Spinal Fixation System | CoreLink, LLC | Primary | |
| K153631 | Zimmer Virage® OCT Spinal | ||
| Fixation System | Zimmer Spine, Inc. | Additional |
PERFORMANCE TESTING SUMMARY
In support of this Special 510(k) Device Modification Premarket Notification, mechanical testing was not required because the worst case components were previously tested under the clearance for K132504.
CONCLUSION
The subject modified is Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is identical to previously cleared Tiger® Occipital-Cervical-Thoracic Spinal Fixation System. The subject Tiger® Occipital-Cervical-Thoracic Spinal Fixation System has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications do not raise any different questions of safety and effectiveness. The overall technology characteristics and mechanical performance data lead to the conclusion that the Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is substantially equivalent to the predicate devices.