| K-number | K254017 |
| Device name | SWINGO-3D Lumbar Cage System |
| Applicant | Implanet |
| Product code | MAX |
| Device class | Class II |
| Decision date | Feb 26, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The SWINGO-3D Lumbar Cage System is an additively manufactured titanium alloy interbody fusion device for skeletally mature patients with degenerative disc disease at one or two contiguous lumbar levels (L2-S1). It stabilizes the spine and promotes bone fusion during surgical correction, is packed with autograft and/or allogeneic bone graft, and must be used with supplemental fixation systems.
The device consists of three models (SWINGO-P-3D for PLIF, SWINGO-T-3D for TLIF, and SWINGO-L-3D for LLIF) made of additively manufactured titanium alloy per ASTM F3001 with various heights and footprints. The hollow geometry allows packing with bone graft material. Devices are provided sterile via gamma irradiation and represent slight geometry differences from the predicate with no new worst case introduced.
ASTM F2077-14 (static and dynamic axial compression and compression shear testing) and ASTM F2267-04 (subsidence testing). Associated instruments conform to ASTM F899 (instrument-grade stainless steel).
The subject device is substantially equivalent to the primary predicate (Shanghai Sanyou Metal Additive Manufacturing Interbody Fusion Cages, K230872) because materials and manufacturing are identical, indications for use are the same, geometry differences introduce no new worst case, and sterility is identical. All prior predicate testing applies; no additional testing is needed.
View the full FDA submission: accessdata.fda.gov