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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.

The SWINGO-3D Lumbar Cage System consists of three different models of additively manufactured lumbar interbody fusion devices—SWINGO-P-3D (PLIF), SWINGO-T-3D (TLIF), and SWINGO-L-3D (LLIF) – that are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. These devices consist of additively manufactured titanium alloy (per ASTM F3001) cages of various heights and footprints, which can be inserted between two lumbar to give support and correction during interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft material. The subject additively manufactured implants are provided sterile via gamma irradiation.

The subject devices are modifications to the nearly-identical devices cleared by Shanghai Sanyou in the predicate submission (K230872). Shanghai Sanyou and Implanet have entered into an agreement in which Implanet will be the legal manufacturer of the subject devices and Shanghai Sanyou will be the contract manufacturer. Under the terms of this agreement, Implanet will maintain the quality system and handle all complaints related to the devices in this submission.

Previously cleared (K163422 and K211689) associated device specific and universal instruments are available to facilitate the implantation of interbody devices. All instruments are manufactured from instrument-grade stainless steel that conforms to ASTM F899. No new instruments are being added.

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