(88 days)
Not Found
No
The document describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
No.
This device is an implantable medical device used to stabilize the cervical spine, acting as an adjunct to fusion for various conditions, rather than providing therapy in the traditional sense of treating disease through non-invasive means.
No
This device is an implantable medical device used for spinal fusion, acting as an adjunct to fusion for stabilization. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of anterior cervical plates, bone screws, and a locking screw, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing the cervical spine during fusion procedures. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as plates, screws, and a locking screw made of titanium alloy. These are physical implants used in surgery.
- Performance Studies: The performance studies focus on mechanical testing (compression, bending, torsion, dissociation) to assess the structural integrity of the implant. This is typical for surgical devices, not IVDs which would involve analytical performance studies.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
Therefore, the Skyway Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis), tumor, pseudarthrosis or failed previous fusion. The 4-Hole 1-Level Plates are limited to use at one contiguous level.
The KMTI Tesera-K SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1 . KMTI Tesera-K SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-K SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
KWQ, OVE
Device Description
The Kyocera Medical Technologies, Inc. (KMT) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6A1-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-K SC System interbody spacers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7), C2-T1
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 Skyway Anterior Cervical Plate System has been tested in the following test modes:
- Static compression bending per ASTM F1717
- Dynamic compression bending per ASTM F1717 ●
- Static torsion per ASTM F1717 ●
- Cage-to-Plate Static Dissociation Testing o
The results of this non-clinical testing show that the strength of the Skyway Anterior Cervical Plate 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.
K221049, K141993, K060025, K152193, K223105
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
§ 888.3060 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.
0
September 12, 2023
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Kyocera Medical Technologies, Inc. (KMTI) % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K231766
Trade/Device Name: Skyway Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ, OVE Dated: August 18, 2023 Received: August 18, 2023
Dear Nathan 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Image /page/1/Picture/6 description: The image contains the text "Colin O'neill -S" in black font. The text is arranged in two lines, with "Colin" on the first line and "O'neill -S" on the second line. To the right of the text, there is a faded, light blue logo that appears to be the letters "FDA".
Colin O'Neill, M.B.E. 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
2
Indications for Use
510(k) Number (if known) K231766
Device Name Skyway Anterior Cervical Plate System
Indications for Use (Describe)
The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis), tumor, pseudarthrosis or failed previous fusion. The 4-Hole 1-Level Plates are limited to use at one contiguous level.
The KMTI Tesera-K SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1 . KMTI Tesera-K SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-K SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.
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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3
K231766 - 510(K) SUMMARY
| Submitter's Name: | Kyocera Medical Technologies, Inc. (KMTI) | |
|---|---|---|
| Submitter's Address: | 1200 California Street | |
| Redlands, California 92374 | ||
| Submitter's Telephone: | 909-557-2360 | |
| Contact Person: | Nathan Wright MS, RAC | |
| Empirical Technologies | ||
| 1-719-351-0248 | ||
| nwright@empiricaltech.com | Image: Empirical Technologies logo | |
| Date Summary was Prepared: | June 15, 2023 | |
| Trade or Proprietary Name: | Skyway Anterior Cervical Plate System | |
| Regulation Name: | Spinal Intervertebral Body Fixation Orthosis, | |
| Intervertebral Fusion Device with Integrated Fixation, Cervical | ||
| Classification & Regulation #: | Class II per 21 CFR §888.3060, 21 CFR§888.3080 | |
| Product Code: | KWQ, OVE | |
| Classification Panel: | Spinal Devices - DHT6B |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Kyocera Medical Technologies, Inc. (KMT) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6A1-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-K SC System interbody spacers.
INDICATIONS FOR USE
The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.
The 4-Hole 1-Level Plates are limited to use at one contiguous level.
The KMTI Tesera-K SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-K SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-K SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.
TECHNOLOGICAL CHARACTERISTICS
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
4
- Materials of manufacture ●
- Plate styles, levels, and sizes
- Screw sizes ●
- Design features
Predicate Devices
| 510k | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate |
|---|---|---|---|---|
| Number | Type | |||
| K221049 | VariSync Plate System | Zavation Medical Products, LLC | OVE, ODP, KWQ | Primary |
| K141993 | Nakoma ACP System | Alliance Partners, LLC | KWQ | Additional |
| K060025 | Slimplicity Anterior Cervical Plate System | Spinal USA (now Precision Spine) | KWQ | Additional |
| K152193 | Renovis Anterior Cervical Plate System | Renovis Surgical Technologies, Inc. | KWQ | Additional |
| K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | OVE, ODP | Additional |
PERFORMANCE DATA
The Skyway Anterior Cervical Plate System has been tested in the following test modes:
- Static compression bending per ASTM F1717
- Dynamic compression bending per ASTM F1717 ●
- Static torsion per ASTM F1717 ●
- Cage-to-Plate Static Dissociation Testing o
The results of this non-clinical testing show that the strength of the Skyway Anterior Cervical Plate 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 Skyway Anterior Cervical Plate System is substantially equivalent to the predicate devices.