The Innovasis Endeavor™ Stand-Alone Cervical IBF System consists of a stand-alone interbody device indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The Endeavor device is intended to be used with the integrated fixation screws provided. The Endeavor device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.

Device Description

The Endeavor™ Stand-Alone Cervical IBF System is an intervertebral body fusion (IBF) device with integrated fixation and associated instrumentation, used with bone graft material, that is intended to stabilize a cervical spinal segment to promote fusion which restricts motion and decreases pain. The Innovasis Endeavor Cervical IBF System is implanted via an Anterior Cervical Discectomy and Fusion (ACDF) surgical approach at one level from C2-T1 and is indicated for use in skeletally mature patients with degenerative disc disease (DDD). The Endeavor implants have a PEEK body enhanced with HA (Hydroxyapatite) and TCP (Tricalcium Phosphate) and feature a titanium faceplate and titanium fixation screws manufactured from titanium alloy per ASTM F136 and Ti-6Al-4V per ASTM F560 features a tapered leading edge to aid in insertion due to limited anatomical space and features a slightly convex profile to match the anatomy and anti-migration teeth to ensure implant stability during the fusion process. The Endeavor implant features a graft cavity to provide volume for graft loading, and is radiolucent allowing assessment of the fusion process, while tantalum spheres per ASTM F560 enable implant visualization during and after the surgical procedure. The implant is available in multiple size options to match vertebral anatomy and is designed to restore height in the cervical spinal column during the fusion process. Implants are supplied sterile. Bone screws and reusable instruments to support the surgery are provided with the implants in sterilization sets.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - Endeavor™ Stand-Alone Cervical IBF System

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

September 25, 2025

Innovasis
Michael Thomas
Director Regulatory Affairs
614 E 3900 S
Salt Lake City, Utah 84107

Re: K250076
Trade/Device Name: Endeavor™ Stand-Alone Cervical IBF System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: OVE
Dated: August 26, 2025
Received: August 26, 2025

Dear Michael Thomas:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K250076 - Michael Thomas Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K250076 - Michael Thomas Page 3

Sincerely,

EILEEN CADEL -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250076

Device Name
Endeavor™ Stand-Alone Cervical IBF System

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

510(k)#: K250076
Prepared on: 2025-09-23

Contact Details

21 CFR 807.92(a)(1)

Field	Value
Applicant Name	Innovasis
Applicant Address	614 E 3900 S Salt Lake City UT 84107 United States
Applicant Contact Telephone	801-261-2236
Applicant Contact	Mr. Michael Thomas
Applicant Contact Email	mthomas@innovasis.com

Device Name

21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	Endeavor™ Stand-Alone Cervical IBF System
Common Name	Intervertebral body fusion device
Classification Name	Intervertebral Fusion Device With Integrated Fixation, Cervical
Regulation Number	888.3080
Product Code(s)	OVE

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K181115	CxHA PEEK Cervical IBF System	ODP
K162236	AxHA Stand-Alone ALIF System	OVD
K220875	HAcancellous PEEK-C Porous HA PEEK Cervical IBF System	ODP
K231899	HAtetracell-C Titanium Cervical IBF System	ODP
K210497	SeaSpine Shoreline ACS - Anterior Cervical Standalone,	OVE

Device Description Summary

21 CFR 807.92(a)(4)

Page 1 of 2

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Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The subject device has substantially equivalent indications for use as predicate device K210497 (SeaSpine Shoreline ACS).

Technological Comparison

21 CFR 807.92(a)(6)

The subject device has substantially equivalent technological characteristics (i.e., design, material, chemical composition, principle of operation) as predicate and reference devices. While the material of the subject device is novel, additional characterization has shown the subject device to perform in a substantially equivalent manner as predicate devices.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

The FDA Guidance for Cervical Intervertebral Body Fusion Devices, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device (issued June 2007) recommends the following testing:

Static and dynamic torsion testing per ASTM F2077
Static and dynamic axial compression testing per ASTM F2077
Static and dynamic compression shear testing per ASTM F2077
Static subsidence testing per ASTM F2267
Static expulsion testing performed per recommendation in above guidance special controls document.

N/A - no clinical data were necessary.

The data submitted in this 510(k) submission demonstrates the substantial equivalence of the subject system as compared to the predicates identified and/or FDA published Cervical IBF data.

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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.