# K220096: Genesys Spine 3DP Lumbar Interbody System

- Pathway: 510(k) (Special)
- Applicant: Genesys Spine
- Decided: Mar 9, 2022 after 56 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). 344 ancestors in all.
No later device cites it as a predicate yet.
1 of 345 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182987: Genesys Spine 3DP Lumbar Interbody System, Genesys Spine (2019) Summary page 4.

## Indications for use
The Genesys Spine 3DP Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K220096
Methodology: https://510kreport.com/methodology