# K254017: SWINGO-3D Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Implanet
- Decided: Feb 26, 2026 after 73 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). 245 ancestors in all.
No later device cites it as a predicate yet.
1 of 246 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230872: Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System, Shanghai Sanyou Medical Co, Ltd. (2023) Summary page 6.
- K163422: Shanghai Sanyou PEEK Cage System, Shanghai Sanyou Medical Co, Ltd. (2017) Summary page 6.
- K211689: KEYSTONE PEEK Cage System, Shanghai Sanyou Medical Co, Ltd. (2021) Summary page 6.

## Indications for use
The SWINGO-3D Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine, at one or two contiguous levels, from L2 to S1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The SWINGO-3D Lumbar Cage System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/ or corticocancellous bone graft when the subject device is used as an adjunct to fusion. When used for these indications, the SWINGO-3D Cage System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K254017
Methodology: https://510kreport.com/methodology