# K254105: Hive™ Standalone Cervical System and Hive™ C Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: NanoHive Medical, LLC
- Decided: Feb 13, 2026 after 56 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 33 generations back to K841189 (1984). 1,436 ancestors in all.
No later device cites it as a predicate yet.
4 of 1,437 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223190: Hive™ Standalone Cervical System, NanoHive Medical, LLC (2022) Summary page 5.
- K241846: E3D™-C Interbody System, Evolution Spine (2024) Summary page 6.
- K180364: HD LifeSciences Cervical IBFD System, Hd Lifesciences, LLC (2018) Summary page 7.
- K212904: SeaSpine WaveForm C Interbody System, SeaSpine Orthopedics Corporation (2021) Summary page 7.
- K213359: SeaSpine WaveForm, C Interbody System, SeaSpine Orthopedics Corporation (2021) Summary page 7.
- K241466: Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System, SeaSpine Orthopedics Corporation (2024) Summary page 7.
- K240838: Spectrum Spine Cervical Cage System, Spectrum Spine, Inc. (2024) Summary page 7.

## Indications for use
The Hive™ Standalone Cervical System, including devices with a microscopic roughened surface and micro and nano-scale features, is indicated at one or more levels of the cervical spine (C2-T1) in skeletally mature patients with cervical degenerative disc disease (DDD), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six (6) weeks of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autogra:ft bone and/or allogra:ft bone comprised of cancellous, cortical, and/or corticocancellous bone. The Hive™ Standalone Cervical System is intended to be used with screws or anchors. When used with two screws, these devices are stand-alone interbody fusion devices. When used with anchors, or without two screws, these devices are intended to be used with supplemental fixation ( e.g. cervical plates or cervical posterior fixation). The Hive™ C Interbody System, including devices with a microscopic roughened surface and micro and nano-scale features, is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to Tl. Patients should have received at least six (6) weeks of non-operative treatment prior to treatment with an interbody fusion device. The Hive™ C Interbody System is indicated to be used with autograft bone and/or allograft bone comprised of cancellous, cortical, and/or corticocancellous bone and/or demineralized allogra:ft bone with bone marrow aspirate to facilitate fusion (hereafter referred to as bone graft). The Hive™ C Interbody System requires additional supplemental fixation cleared for use in the cervical spine.

Source page: https://510kreport.com/device/K254105
Methodology: https://510kreport.com/methodology