# K242509: HAnano InterFuse (R) Modular Interbody

- Pathway: 510(k) (Special)
- Applicant: Next Orthosurgical
- Decided: Sep 19, 2024 after 28 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: 24 generations back to K841189 (1984). 411 ancestors in all.
No later device cites it as a predicate yet.
1 of 412 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091988: Modification to: Interfuse Intervertebral Body Fusion Device , Model 9076, Vertebral Technologies, Inc. (2009) Summary page 5.
- K222561: Align, Acuity Surgical Devices, LLC (2022) Summary page 5.
- K201614: TxTiHA IBF System, AxTiHA Stand-Alone ALIF System, Innovasis, Inc. (2020) Summary page 5.

## Indications for use
The HAnano InterFuse® Modular Interbody is intended to be used for spinal fusion procedures 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. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The HAnano InterFuse® device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The HAnano InterFuse® device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Source page: https://510kreport.com/device/K242509
Methodology: https://510kreport.com/methodology