# K201287: Impulse Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Degen Medical
- Decided: Dec 22, 2020 after 222 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: 25 generations back to K841189 (1984). 417 ancestors in all.
8 later devices descend from it; 1 cites it directly.
1 of 426 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130478: Sustain and Sustain Radiolucent Spacers, Globus Medical, Inc. (2013) Summary page 4.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 4.
- K163481: HALF DOME Posterior Lumbar Interbody System, Astura Medical (2017) Summary page 4.
- K092193: Spinal Usa Interbody Cages, Spinal USA (2009) Summary page 4.
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019) Summary page 4.

## Most influential descendants
- K210090: Impulse AM Interbody Fusion System (2021), 7 descendants of its own
- K223418: DeGen Impulse AM™ System (2023), 6 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own
- K240326: Solar™ Lumbar Interbody Fusion System (2024), 4 descendants of its own
- K241077: DeGen Medical Patient Specific Implant (PSI) System (2024), 2 descendants of its own

## Indications for use
The DeGen Medical Impulse implant is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse System is indicated to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and are intended to be used with supplemental fixation systems cleared for use in the lumbar spine. The device is to be used in patients who have had six months of nonoperative treatment.

Source page: https://510kreport.com/device/K201287
Methodology: https://510kreport.com/methodology