# K231371: BEE Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: NGMedical GmbH
- Decided: Jan 12, 2024 after 245 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K200429: BEE Cages, NGMedical GmbH (2021). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K220696: uCerv Flux-C 3D Porous Titanium Cervical Interbody, Ulrich Medical USA (2022). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K250560: BEE HA (2025), 0 descendants of its own

## Indications for use
BEE Cervical Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE Cervical Cages are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

Source page: https://510kreport.com/device/K231371
Methodology: https://510kreport.com/methodology