(83 days)
No
The summary describes a mechanical spinal fusion system and its materials, with no mention of AI or ML capabilities.
No
The device is an implantable spinal fusion system designed to provide mechanical support, not directly treat a disease or condition.
No
The device is an implantable spinal fusion system designed to provide mechanical support and promote arthrodesis, not to diagnose a condition.
No
The device description explicitly states it consists of additively manufactured interbody devices and machined titanium bone screws and locking bolts, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the KMTI Tesera-K SC System is for "intervertebral body fusion procedures" in the cervical spine. This is a surgical procedure involving the implantation of a device into the body.
- Device Description: The device is described as a "spinal fusion system consisting of additively manufactured interbody devices and machined titanium bone screws and locking bolts." These are physical implants designed to provide mechanical support.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The KMTI Tesera-K SC System does not perform any such tests.
The KMTI Tesera-K SC System is a surgical implant used in a fusion procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
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.
The KMTI Tesera-K SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of two (2) bone screws and the locking bolt.
When used without the locking bolt and two screws, the KMTI Tesera-K SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.
Product codes
OVE, ODP
Device Description
The Tesera-K SC System (Tesera-K SC) is a spinal fusion system consisting of additively manufactured interbody devices and machined titanium bone screws and locking bolts. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tesera-K SC implants are available in a variety of lordosis and footprint options with a superior and inferior porous face and internal lattice structure to offer increased capacity for bone growth.
The Tesera-K SC cages are additively manufactured then machined from Titanium alloy (Ti-6Al-4V) per ASTM F2924, and the bone screws and locking bolts are machined from Titanium alloy (Ti-6Al-4V) per ASTM F136.
The Tesera-K SC System may be implanted as a standalone with two internal fixation screws and the locking bolt and without supplemental fixation or may be implanted as a non-standalone system without the internal fixation screws and locking bolt but with FDA-cleared supplemental fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-T1
Indicated Patient Age Range
skeletally mature
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 Tesera-K SC System has been tested in the following test modes:
- Static and dynamic axial compression per ASTM F2077
- Static and dynamic compression shear per ASTM F2077
- Static and dynamic torsion per ASTM F2077
- Subsidence per ASTM F2267 .
The results of this non-clinical testing show that the strength of the Tesera-K SC 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)
K212853, K211111, K173077, K153250
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
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December 22, 2022
Kyocera Medical Technologies, Inc. % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K223105
Trade/Device Name: Tesera-K SC System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: September 30, 2022 Received: September 30, 2022
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.
1
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) 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 medical devices and radiation-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.
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. 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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Indications for Use
510(k) Number (if known) K223105
Device Name Tesera-K SC System
Indications for Use (Describe)
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.
The KMTI Tesera-K SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the use of two (2) bone screws and the locking bolt.
When used without the locking bolt and two screws, the KMTI Tesera-K SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.
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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K223105 - 510(K) SUMMARY
| Submitter's Name: | Kyocera Medical Technologies, Inc. (KMTI) |
|---|---|
| Submitter's Address: | 1200 California Street, Suite 210 |
| Redlands, California 92374 | |
| Submitter's Telephone: | 909-557-2360 |
| Contact Person: | Nathan Wright MS |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: Empirical Technologies Logo | |
| Date Summary was Prepared: | September 29, 2022 |
| Trade or Proprietary Name: | Tesera-K SC System |
| Classification Name: | Intervertebral Body Fusion Device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE, ODP |
| Classification Panel: | Orthopedic – Spinal (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Tesera-K SC System (Tesera-K SC) is a spinal fusion system consisting of additively manufactured interbody devices and machined titanium bone screws and locking bolts. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tesera-K SC implants are available in a variety of lordosis and footprint options with a superior and inferior porous face and internal lattice structure to offer increased capacity for bone growth.
The Tesera-K SC cages are additively manufactured then machined from Titanium alloy (Ti-6Al-4V) per ASTM F2924, and the bone screws and locking bolts are machined from Titanium alloy (Ti-6Al-4V) per ASTM F136.
The Tesera-K SC System may be implanted as a standalone with two internal fixation screws and the locking bolt and without supplemental fixation or may be implanted as a non-standalone system without the internal fixation screws and locking bolt but with FDA-cleared supplemental fixation.
INDICATIONS FOR USE
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. KMT1 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.
The KMTI Tesera-K SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of two (2) bone screws and the locking bolt.
When used without the locking bolt and two screws, the KMTI Tesera-K SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.
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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 the same between the subject and predicates:
- Indications for Use
- Principle of operation
- Structural support mechanism
- Materials of manufacture ●
- Mechanical strength ●
- Cage Sizes ●
- Screw Sizes ●
- Manufacturing and Biocompatibility ●
Predicate Devices
| 510k | Trade or Proprietary or Model Name | Manufacturer | Product | Predicate |
|---|---|---|---|---|
| Number | Code | Type | ||
| K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | OVE | Primary |
| K211111 | SureMAX-SA Cervical Standalone System | Additive Implants, Inc. | OVE | Additional |
| K173077 | Cavetto®-SA Cervical Cage System | Neurostructures, Inc | OVE | Additional |
| K153250 | Tesera SC Stand-Alone Cervical Fusion (ACF) | Renovis Surgical Technologies, Inc. | OVE, ODP | Additional |
| K212980 | Tesera-k ALIF System | Kyocera Medical Technologies, Inc. | OVD, MAX | Reference |
PERFORMANCE DATA
The Tesera-K SC System has been tested in the following test modes:
- Static and dynamic axial compression per ASTM F2077 ●
- Static and dynamic compression shear per ASTM F2077 ●
- Static and dynamic torsion per ASTM F2077 ●
- Subsidence per ASTM F2267 .
The results of this non-clinical testing show that the strength of the Tesera-K SC 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 conclusion that the Tesera-K SC System is substantially equivalent to the predicate devices.