# K250602: X-PAC® N-GAGE™ Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Expanding Innovations, Inc.
- Decided: May 20, 2025 after 81 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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). 465 ancestors in all.
No later device cites it as a predicate yet.
1 of 466 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200885: Meridian Anterior Plate System, Regatta Lateral Plate System, SeaSpine Orthopedics Corporation (2020) Summary page 5.
- K200879: SeaSpine Meridian System, SeaSpine Regatta Lateral System, SeaSpine Orthopedics Corporation (2020) Summary page 5.
- K223174: X-Pac Expandable LLIF Cage System, Expanding Innovations, Inc. (2023) Summary page 5.

## Indications for use
X-PAC® N-GAGE™ Lumbar Plate System: X-PAC® N-GAGE™ 2-Hole and 4-Hole Lumbar Plate System is indicated for temporary stabilization during spinal fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1‐L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1‐S1) spine instability in skeletally mature patients for the treatment of degenerative disc disease (DDD), spondylolisthesis, spondylolysis, spinal stenosis, pseudoarthrosis, deformity (defined as scoliosis, kyphosis, or lordosis), tumors, trauma (i.e. fractures including dislocation and subluxation), and/or failed previous fusion. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. X-PAC® Plate-Cage System: N-GAGE™ 2-Hole and 4-Hole Plates may be assembled with the X-PAC® LLIF Expandable Cage to create a plate-spacer assembly. When assembled to the X-PAC® LLIF Expandable Cage, the plate-spacer assembly is indicated for standalone use at one or two levels of the lumbosacral spine (L2-S1), as an adjunct to fusion in skeletally mature patient with degenerative disc disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have at least six (6) months of non-operative treatment. N-GAGE™ 1-Hole Plate is to be assembled with the X-PAC® LLIF Expandable Cages. When assembled, the system is intended to maintain the relative position of X-PAC® LLIF Expandable Cage and intended for use with supplemental fixation (e.g., posterior spinal systems).

Source page: https://510kreport.com/device/K250602
Methodology: https://510kreport.com/methodology