# K200879: SeaSpine Meridian System, SeaSpine Regatta Lateral System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Jun 10, 2020 after 69 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: 20 generations back to K841189 (1984). 290 ancestors in all.
60 later devices descend from it; 6 cite it directly.
0 of 351 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101310: VU Apod Intervertebral Body Fusion Device, Theken Spine, LLC (2010) Summary page 5.
- K162351: SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device, SeaSpine Orthopedics Corporation (2016) Summary page 5.
- K181079: SeaSpine Regatta Lateral System, SeaSpine Orthopedics Corporation (2018) Summary page 5.

## Most influential descendants
- K210497: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System (2021), 39 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own
- K201193: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L  NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System (2020), 18 descendants of its own
- K210583: SeaSpine WaveForm™ A Interbody System (2021), 14 descendants of its own
- K220711: SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System (2022), 10 descendants of its own

## Indications for use
SeaSpine Meridian System Interbody Device (IBD) Implants (i.e., interbody implants used alone): The SeaSpine Meridian System interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. No-Profile Implants w/ Screws: The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation. No-Profile Implants w/ Inline Fixation Anchors: The SeaSpine Meridian System No-Profile Interbody, when used with Inline Fixation Anchors and a No-Profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation. TruProfile Interbody Implants: The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and a Anterior Plate Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation. SeaSpine Regatta Lateral System Interbody Device (IBD) Implants (i.e., interbody implants used alone): The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Regatta Lateral System is intended for use with supplemental fixation. TruProfile Interbody Implants: The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

Source page: https://510kreport.com/device/K200879
Methodology: https://510kreport.com/methodology