# K231241: NanoHive Medical Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: NanoHive Medical, LLC
- Decided: Jul 12, 2023 after 75 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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). 401 ancestors in all.
No later device cites it as a predicate yet.
1 of 402 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170676: HD Lumbar Interbody System, Hd Lifesciences, LLC (2017) Summary page 5.
- K201605: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage, Eit Emerging Implant Technologies GmbH (2020) Summary page 5.
- K181380: LnK Lumbar Interbody Fusion Cage System, L&K BIOMED Co., Ltd. (2018) Summary page 5.
- K210800: IO Expandable Lumbar Interbody Fusion System, MiRus, LLC (2021) Summary page 5.
- K181589: Curiteva Lumbar Interbody Fusion System, Curiteva, LLC (2018) Summary page 5.

## Indications for use
The NanoHive Medical Lumbar Interbody System, with a microscopic roughened surface and micro and nano-scale features, is indicated for use in skeletally mature patients with Degenerative Disc Disease (DOD) at one or two contiguous levels from L2-S1. DOD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DOD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone (hereafter bone graft).

Source page: https://510kreport.com/device/K231241
Methodology: https://510kreport.com/methodology