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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Keos Anterior Cervical Interbody Fusion Device System. This document focuses on demonstrating substantial equivalence to previously cleared devices through performance testing, rather than an AI/ML device study. Therefore, most of the requested information about acceptance criteria, study method, sample sizes, ground truth establishment, and expert involvement is not applicable or cannot be extracted from this document, as it pertains to a different type of device evaluation.

However, I can provide the information available regarding the performance testing that was conducted.

Summary of Performance Testing for Keos Anterior Cervical Interbody Fusion Device System (K212450)

This device is a physical medical implant (Interbody Fusion Device), not an AI/ML-based diagnostic or therapeutic system. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training sets) are not relevant to this submission.

The acceptance criteria and device performance are related to mechanical and biocompatibility testing of the physical implant as per relevant ASTM standards.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (General)	Reported Device Performance (General)
Mechanical Testing	Performance demonstrated to be substantially equivalent to predicate devices. Specific standards followed: ASTM F2077 (for static axial compression, dynamic axial compression shear, dynamic compression shear, static torsion, dynamic torsion, and subsidence) and ASTM F2267. This implies meeting or exceeding the mechanical performance characteristics of the predicate devices under these test conditions, ensuring structural integrity, stability, and resistance to subsidence or failure under physiological loads. Acceptance criteria would typically include thresholds for displacement, load to yield, fatigue life, and other mechanical parameters as defined within the ASTM standards and compared against predicate devices.	All tests confirmed that the product met the predetermined acceptance criteria. Non-clinical bench performance testing demonstrated that the Keos Anterior Cervical IBFDs are substantially equivalent to previously cleared devices based on mechanical performance.
Static Axial Compression	As per ASTM F2077, likely involves specific load-bearing capacity without permanent deformation.	Met criteria, demonstrating substantial equivalence.
Dynamic Axial Compression	As per ASTM F2077, likely involves fatigue life under cyclic axial loading.	Met criteria, demonstrating substantial equivalence.
Dynamic Compression Shear	As per ASTM F2077, likely involves fatigue life under cyclic shear loading.	Met criteria, demonstrating substantial equivalence.
Static Torsion	As per ASTM F2077, likely involves resistance to torsional forces without permanent deformation.	Met criteria, demonstrating substantial equivalence.
Dynamic Torsion	As per ASTM F2077, likely involves fatigue life under cyclic torsional loading.	Met criteria, demonstrating substantial equivalence.
Subsidence	As per ASTM F2077, likely involves resistance to sinking into vertebral bone under load.	Met criteria, demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical implant testing, not an AI/ML-based study with a test set of data. The "test set" would be the number of physical devices tested according to the ASTM standards. The provenance is from bench testing in a laboratory setting. Specific numbers of devices tested are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, is established by industry standards (ASTM) and engineering principles for mechanical performance, not expert consensus interpreting medical images or data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This term relates to human interpretation/review of data, which is not part of this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI/ML devices.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML devices.

7. The type of ground truth used:

Mechanical Performance: Established by adherence to the requirements and methodologies outlined in ASTM F2077 and ASTM F2267 standards for intervertebral body fusion devices. The "ground truth" is therefore consistency with established engineering principles and performance benchmarks for such implants.

8. The sample size for the training set: Not applicable. This is for AI/ML devices.

9. How the ground truth for the training set was established: Not applicable. This is for AI/ML devices.

Summary

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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

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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)

K212450

Device Name

Keos Anterior Cervical Interbody Fusion Devices

Indications for Use (Describe)

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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510(k) Summary Keos Anterior Cervical Interbody Fusion Device System 12 May 2022

Company:	Keos1824 Colonial Village LaneLancaster, PA, 17601 USAPhone: (239) 259-1491
Company Contact:	Scott Peterson - KeosPhone: 239-259-1491Fax: 239-216-8131Email: speterson@keosspine.com
Official Correspondent:	Maris Garner – MRC Global, LLCmaris.garner@askmrcglobal.com601-946-2244
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:

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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.

Regulation Number and Section

§ 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.