# K250076: Endeavor™ Stand-Alone Cervical IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis
- Decided: Sep 25, 2025 after 258 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K841189 (1984). 404 ancestors in all.
No later device cites it as a predicate yet.
1 of 405 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181115: CxHA PEEK Cervical IBF System, Innovasis, Inc. (2018) Summary page 5.
- K162236: Ax Stand-Alone ALIF System, Innovasis, Inc. (2017) Summary page 5.
- K220875: HAcancellous PEEK-C Porous HA PEEK Cervical IBF System, Innovasis, Inc. (2022) Summary page 5.
- K231899: HAtetracell™-C Titanium Cervical IBF System, Innovasis, Inc. (2023) Summary page 5.
- K210497: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System, SeaSpine Orthopedics Corporation (2021) Summary page 5.

## Indications for use
The Innovasis Endeavor TM 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.

Source page: https://510kreport.com/device/K250076
Methodology: https://510kreport.com/methodology