(305 days)
No
The summary describes a passive implantable device made of PEEK and HA, with no mention of software, algorithms, or any computational capabilities that would suggest the use of AI or ML. The performance studies are mechanical tests, not related to data analysis or image processing.
Yes
The device is specifically designed to facilitate intervertebral body fusion in the cervical spine to treat degenerative disc disease and associated symptoms, which falls under the definition of a therapeutic intervention.
No
Explanation: The device is an interbody fusion device designed to facilitate spinal fusion, not to diagnose a condition. Its function is therapeutic, involving physical implantation and support for bone growth.
No
The device description explicitly details physical hardware components made of PEEK, HA-enhanced PEEK, and tantalum, intended for surgical implantation. It also mentions associated instruments. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Keos Anterior Cervical Interbody Fusion Device is an implantable medical device made of PEEK and HA-enhanced PEEK. It is surgically placed in the cervical spine to facilitate bone fusion.
- Intended Use: The intended use is to treat degenerative disc disease in the cervical spine by facilitating intervertebral body fusion. This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant used for treatment, not a diagnostic tool used to analyze biological samples.
N/A
Intended Use / Indications for Use
The Keos Anterior Cervical Interbody Fusion Devices (IBFDs) are in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Keos Anterior Cervical IBFD's are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autogenous bone graft. Keos Anterior Cervical IBFD's are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The subject Keos Anterior Cervical Interbody Fusion Device (IBFD) System is composed of anterior cervical spacers and associated instruments. Keos Anterior Cervical IBFD cages are manufactured from polyetheretherketone (PEEK) according to ASTM F2026, as well as Hydroxyapaetite (HA) Enhanced PEEK. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Keos Anterior Cervical IBFD cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. Additionally, the device contains six (6) tantalum marker balls per ASTM F560 to provide imaging visibility for device positioning.
The Keos Anterior Cervical Interbody Fusion Device System implants are intended for single use only. All components of the Keos Anterior Cervical IBFD System are provided non-sterile, to be sterilized by the end user.
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 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, including static axial compression, dynamic axial compression shear, dynamic compression shear, static torsion, dynamic torsion and subsidence, was performed according to ASTM F2077 and ASTM F2267. All tests confirmed that the product met the predetermined acceptance criteria. In particular, non-clinical bench performance testing demonstrated that the Keos Anterior Cervical IBFDs are substantially equivalent to previously cleared devices. Performance testing results are summarized in the Performance Testing - Bench section of this Traditional 510(k).
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.
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.
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June 6, 2022
Keos % Maris Garner Senior Consultant MRC Global, LLC 9085 East Mineral Circle, Suite 110 Centennial. Colorado 80112
Re: K212450
Trade/Device Name: Keos Anterior Cervical Interbody Fusion Device System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 12, 2022 Received: May 13, 2022
Dear Ms. Garner:
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
1
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,
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)
Device Name
Keos Anterior Cervical Interbody Fusion Devices
Indications for Use (Describe)
The Keos Anterior Cervical Interbody Fusion Devices (IBFDs) are in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Keos Anterior Cervical IBFD's are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autogenous bone graft. Keos Anterior Cervical IBFD's are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
| 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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3
510(k) Summary Keos Anterior Cervical Interbody Fusion Device System 12 May 2022
| Company: | Keos
1824 Colonial Village Lane
Lancaster, PA, 17601 USA
Phone: (239) 259-1491 |
|-------------------------|-----------------------------------------------------------------------------------------------------|
| Company Contact: | Scott Peterson - Keos
Phone: 239-259-1491
Fax: 239-216-8131
Email: speterson@keosspine.com |
| Official Correspondent: | Maris Garner – MRC Global, LLC
maris.garner@askmrcglobal.com
601-946-2244 |
| Trade Name: | Keos Anterior Cervical Interbody Fusion Device System |
| Common Name: | Intervertebral Fusion Device With Bone Graft, Cervical |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) |
| Panel: | Orthopedic |
| Product Code: | ODP |
Device Description:
The subject Keos Anterior Cervical Interbody Fusion Device (IBFD) System is composed of anterior cervical spacers and associated instruments. Keos Anterior Cervical IBFD cages are manufactured from polyetheretherketone (PEEK) according to ASTM F2026, as well as Hydroxyapaetite (HA) Enhanced PEEK. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Keos Anterior Cervical IBFD cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. Additionally, the device contains six (6) tantalum marker balls per ASTM F560 to provide imaging visibility for device positioning.
The Keos Anterior Cervical Interbody Fusion Device System implants are intended for single use only. All components of the Keos Anterior Cervical IBFD System are provided non-sterile, to be sterilized by the end user.
4
Indications for Use:
The Keos Anterior Cervical Interbody Fusion Devices (IBFDs) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Keos Anterior Cervical IBFD's are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autogenous bone graft. Keos Anterior Cervical IBFD's are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Substantial Equivalence:
The subject device is substantially equivalent to the following predicate devices: Primary Predicate: BeSpoke Technologies - Tailored-C Cervical IBFD - K200458
Secondary Predicate: Meditech Spine, LLC - Talos®-C (HA) - K142345
Reference Devices: Keos – Lumbar Intervertebral Body Fusion Device – K163386, K193174
The subject devices are similar in design to the BeSpoke Technologies Tailored-C Cervical IBFD (K200458) and are designed to be used with the Bespoke Technologies Tailored-C Cervical IBFD instruments. The subject Keos Anterior Cervical IBFDs are manufactured from PEEK-Optima and HA Enhanced PEEK-Optima, similar to the secondary predicate, Talos® C HA (K142345). The materials are identical to those of the Keos Lumbar IBFDs (K163386, K193174).
Performance Testing:
Mechanical testing, including static axial compression, dynamic axial compression shear, dynamic compression shear, static torsion, dynamic torsion and subsidence, was performed according to ASTM F2077 and ASTM F2267. All tests confirmed that the product met the predetermined acceptance criteria. In particular, non-clinical bench performance testing demonstrated that the Keos Anterior Cervical IBFDs are substantially equivalent to previously cleared devices. Performance testing results are summarized in the Performance Testing - Bench section of this Traditional 510(k).
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.