# K223190: Hive™ Standalone Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: NanoHive Medical, LLC
- Decided: Dec 12, 2022 after 60 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: 27 generations back to K841189 (1984). 608 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 614 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212904: SeaSpine WaveForm C Interbody System, SeaSpine Orthopedics Corporation (2021) Summary page 5.
- K212853: Cervical Stand-Alone System, Eminent Spine, LLC (2021) Summary page 5.
- K190885: Elevation Spine Saber-C System, Elevation Spine (2019) Summary page 5.

## Most influential descendants
- K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (2024), 3 descendants of its own
- K250827: aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams (2025), 2 descendants of its own
- K252894: aprevo® cervical interbody system (2026), 1 descendant of its own
- K260385: aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system (2026), 0 descendants of its own
- K254105: Hive™ Standalone Cervical System and Hive™ C Interbody System (2026), 0 descendants of its own

## Indications for use
The Hive™ Standalone Cervical System with NanoHive® Surface Technology is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous or corticocancellous bone. These devices are intended to be used with the screws which accompany the implants. When used with the accompanying screws, these devices may be used as standalone interbody devices. If the accompanying screws are not used, the device is intended for use with supplemental fixation. When used as a standalone system, the Hive™ Standalone Cervical System is intended for use at one or two levels (C2-T1) and must be used with the provided bone screws.

Source page: https://510kreport.com/device/K223190
Methodology: https://510kreport.com/methodology