(70 days)
No
The 510(k) summary describes a physical implant (cervical interbody fusion device) and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat degenerative disc disease and accompanying radicular symptoms by facilitating interbody fusion, which clearly aligns with the definition of a therapeutic device.
No
This device is an interbody fusion device, specifically a cervical spacer, designed for surgical implantation to assist in spinal fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical implants made from Polyetheretherketone and titanium alloy, which are hardware 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 surgical implant for spinal fusion. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device is described as an interbody spacer implant made of materials like PEEK and titanium alloy, designed to be surgically placed in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is a therapeutic implant used directly within the body.
N/A
Intended Use / Indications for Use
The CHENA-C Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The CHENA-C Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The CHENA-C Spacer is intended to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Kahtnu (previously Axis Orthopaedics) Chena-C Spacer System is consists of a variety of footprints and heights of cervical interbody spacer implants to assist in interbody fusion. The previously cleared Axis Chena Cervical PEEK Spacer System (K181140) implant components are fabricated from medical implant grade Polyetheretherketone and tantalum per ASTM F2026-17 and ASTM F560-17. The purpose of this Special 510(k) submission is to add titanium alloy (ASTM F136) cervical cages to the Chena-C Spacer System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-T1 (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing was performed on the predicate Chena Cervical PEEK Spacers. The subject devices have been evaluated and the results of evaluation have shown that no new worst case is presented compared to the predicate devices. Therefore, no testing is required.
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.
K180301, K120275, K133784, K142251
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
§ 888.3080 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 6, 2021
Kahtnu Surgical. Inc % Ann Dunahoo Principal Regulatory And Quality Consultant MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, Colorado 80112
Re: K213115
Trade/Device Name: CHENA-C Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 10, 2021 Received: November 12, 2021
Dear Ms. Dunahoo:
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
K213115 - Ms. Ann Dunahoo
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,
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) K213115
Device Name CHENA-C Spacer System
Indications for Use (Describe)
The CHENA-C Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The CHENA-C Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The CHENA-C Spacer is intended to be used with 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
K213115
510(k) Summary
CHENA-C Spacer System September 23, 2021
| Company: | Kahtnu Surgical, Inc.
170 E. Corral Ave. Suite 1
Soldotna, AK 99669 |
|-------------------------------|------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Ann Dunahoo
Principal Quality and Regulatory Consultant
901-299-9390
ann.dunahoo@askmrcglobal.com |
| Company/Secondary
Contact: | Craig Wilcox
President and CEO
907-202-3111
craig.wilcox@kahtnu.com |
| Trade Name: | CHENA-C Spacer System |
| Common Name: | Intervertebral Fusion Device With Bone Graft, Cervical |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) |
| Panel: | 87-Orthopedic |
| Product Code: | ODP |
Device Description:
The Kahtnu (previously Axis Orthopaedics) Chena-C Spacer System is consists of a variety of footprints and heights of cervical interbody spacer implants to assist in interbody fusion. The previously cleared Axis Chena Cervical PEEK Spacer System (K181140) implant components are fabricated from medical implant grade Polyetheretherketone and tantalum per ASTM F2026-17 and ASTM F560-17. The purpose of this Special 510(k) submission is to add titanium alloy (ASTM F136) cervical cages to the Chena-C Spacer System.
Indications for Use:
The CHENA-C Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-Tl. DDD is defined as discogenic pain
K213115 510k Summary Page 1 of 2
4
with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The CHENA-C Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The CHENA-C Spacer is intended to be used with supplemental fixation.
Substantial Equivalence:
The subject Chena-C Spacer System is substantially equivalent to the following predicate devices:
- . Primary Predicate: Axis Orthopedics – Chena Cervical PEEK Spacer System (K181140; S.E. 11/16/2018)
- . Secondary Predicate: Alliance Spine, Alamo® C - K173128 (S.E. 3/22/2018)
. Reference Devices:
Axis 5.5 Lumbar Pedicle Screw System (Now Axis Talkeetna) – K180301 (S.E. 4/10/2018) DePuy Synthes ACIS - K120275 (S.E. 5/25/2012) Zimmer Vista®-S Device – K133784 (S.E. 7/7/2014) Stryker AVS® AS PEEK Spacer – K142251 (S.E. 11/19/2014)
The Indications for Use are identical between the subject and primary predicate devices. The Materials are identical to the secondary predicate device as well as the reference devices. While the subject device does contain a slight change in geometry to incorporate a larger graft window, it has been shown to be mechanically equivalent to the primary predicate device. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
Mechanical testing was performed on the predicate Chena Cervical PEEK Spacers. The subject devices have been evaluated and the results of evaluation have shown that no new worst case is presented compared to the predicate devices. Therefore, no testing is required
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.