# K201939: GAIA Lumbar Interbody Fusion Device (LIFD) Family

- Pathway: 510(k) (Traditional)
- Applicant: Printerprezz
- Decided: Oct 8, 2020 after 87 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: 21 generations back to K841189 (1984). 303 ancestors in all.
No later device cites it as a predicate yet.
1 of 304 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170676: HD Lumbar Interbody System, Hd Lifesciences, LLC (2017) Summary page 6.
- K172816: TiGer Shark™ System, Choicespine, LP (2018) Summary page 6.
- K162496: Foundation 3D Interbody, Corelink, LLC (2017) Summary page 6.
- K143258: PLIF STS, TLIF STS, OLIF STS (Spinal Truss System), 4Web, Inc. (2015) Summary page 6.
- K180556: Corelink Foundation 3D Anterior Lumbar System, Corelink, LLC (2018) Summary page 6.
- K190483: SPIRA Open Matrix ALIF and LLIF, Camber Spine Technologies (2019) Summary page 6.
- K111354: GS Medical Anyplus Peek Lumbar Cages (Alif and Dlif), GS Medical Co., Ltd. (2011) Summary page 6.
- K131612: Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif Peek Cages, GS Medical Co., Ltd. (2014) Summary page 6.

## Indications for use
The ASTRAEUS anterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ASTRAEUS ALIF cage is to be implanted via an anterior approach. The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The PROMETHEUS PLIF cage is to be implanted via a posterior approach. The THEMIS Transforaminal posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. GAIA devices, including the THEMIS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.

Source page: https://510kreport.com/device/K201939
Methodology: https://510kreport.com/methodology