# K200541: Hive™ Stand-alone Anterior Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Hd Lifesciences, LLC
- Decided: Apr 28, 2020 after 56 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 21 generations back to K841189 (1984). 313 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 315 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 4.
- K180814: CoreLink® M3™ Stand-Alone Anterior Lumbar System, Corelink, LLC (2018) Summary page 5.
- K180502: S128 Anterior Lumbar Interbody Fusion (ALIF) System, Renovis Surgical Technologies, Inc. (2018) Summary page 5.
- K182195: Arco™-SA Lumbar Cage System, Neurostructures, Inc. (2018) Summary page 5.

## Most influential descendants
- K202820: Australis Anterior Lumbar Cage System (2020), 0 descendants of its own

## Indications for use
The HD LifeSciences Hive™ Stand-alone Anterior Lumbar Interbody System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD 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. These DDD 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. 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 stand- alone interbody devices. If the accompanying screws are not used the device is intended for use with supplemental fixation. Hyperlordotic implants (20° and greater lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K200541
Methodology: https://510kreport.com/methodology