510(k) · Cleared
ClearedSeaSpine 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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 7, 2021 as substantially equivalent to K142488 (Seaspine, Inc., 2014) and 9 other predicates after a 135-day review. Its family tree reaches back 22 generations to 1984. 1 of the 406 devices in its family, counting itself, has a Class I recall. 39 later devices descend from it.
- Decided
- Jul 7, 2021
- Review
- 135 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 22 generations to K841189 (1984). 366 ancestors in all, the oldest K792352 (1979). 39 later devices descend from it, 6 citing it directly. 1 of the 406 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
- 2 generations backK192132 SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · Recalled
- 1 generation backK193636 SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation · 2020
- This deviceK210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2021
- Descendant · cites it directly · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · 2 generations on · 7 of its ownK240368 E3D™-A Interbody SystemEvolution Spine · 2024
- Descendant · 2 generations on · 7 of its ownK232097 IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 7 of its ownK231438 Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023
- Descendant · 2 generations on · 7 of its ownK223611 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 12 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 11 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 10 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 9 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 8 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 7 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 6 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 5 generations backK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- 4 generations backK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
- 3 generations backK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
- 2 generations backK192132 SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · Recalled
- 1 generation backK193636 SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation · 2020
- This deviceK210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2021
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 39 · See all- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · cites it directly28descendants
- K240368E3D™-A Interbody SystemEvolution Spine · 2024 · 2 generations on7descendants
- K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · 2 generations on7descendants
- K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023 · 2 generations on7descendants
- K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −12 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −11 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −10 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −9 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −8 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −7 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −6 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −5 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| −4 | K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2016 | — |
| −3 | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura… | SeaSpine Orthopedics Corporation | 2017 | — |
| −2 | K192132 | SeaSpine Beachside System | SeaSpine Orthopedics Corporation | 2019 | 1 |
| −1 | K193636 | SeaSpine Reef TH System | SeaSpine Orthopedics Corporation | 2020 | — |
| 0 (this device) | K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2021 | — |
| +1 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +2 | K240368 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
| +2 | K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023 | 1 |
| +2 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| +2 | K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 19 | 0 |
| 2004 | 38 | 0 |
| 2005 | 24 | 0 |
| 2006 | 15 | 0 |
| 2007 | 18 | 0 |
| 2008 | 42 | 1 |
| 2009 | 28 | 0 |
| 2010 | 22 | 0 |
| 2011 | 25 | 0 |
| 2012 | 15 | 0 |
| 2013 | 19 | 0 |
| 2014 | 15 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 7 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Summary page 17…Code Primary Predicate SeaSpine Spacer System – MAX, (Hollywood NanoMetalene, K142488, ODP, Hollywood VI NanoMetalene, SeaSpine Orthopedics K173260 MQP Pacifica N… | 2014 |
| * | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…Summary page 17…ystem – MAX, (Hollywood NanoMetalene, K142488, ODP, Hollywood VI NanoMetalene, SeaSpine Orthopedics K173260 MQP Pacifica NanoMetalene, Corporation Redondo NanoMeta… | 2017 |
| * | K173606 | SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…Summary page 17…MQP SeaSpine Vu a•POD Prime SeaSpine Orthopedics K173606 OVD NanoMetalene Intervertebral Co… | 2018 |
| * | K190655 | SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSummary page 17…Device SeaSpine Shoreline ACS – SeaSpine Orthopedics K190655 OVD Anterior Cervical Standalone C… | 2019 |
| * | K171046 | SeaSpine Cambria SystemSummary page 17…Corporation System SeaSpine Orthopedics K171046 ODP SeaSpine Cambria System Corp… | 2017 |
| * | K181079 | SeaSpine Regatta Lateral SystemSummary page 17…Corporation SeaSpine Orthopedics K181079 MAX SeaSpine Regatta Lateral System… | 2018 |
| * | K183083 | Shoreline Cervical Interbody RT SystemSummary page 17…Corporation OVE, Shoreline Cervical Interbody RT SeaSpine Orthopedics K183083 ODP System Corporation SeaS… | 2019 |
| * | K192132 | SeaSpine Beachside SystemSummary page 17…ration SeaSpine Reef TO/TA System SeaSpine Orthopedics K192132 MAX (formerly SeaSpine Beachside C… | 2019 |
| * | K193636 | SeaSpine Reef TH SystemSummary page 17…Corporation System) SeaSpine Orthopedics K193636 MAX SeaSpine Reef TH System Corp… | 2020 |
| * | K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSummary page 17…Corporation MAX, SeaSpine Orthopedics K200879 SeaSpine Meridian System OVD Cor… | 2020 |
What descends from it? (39)
See all 396 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™… | 2022 | 28 |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | 2024 | 5 |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System… | 2024 | 3 |
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior… | 2023 | 3 |
| K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody… | 2024 | 2 |
| K250076 | Endeavor™ Stand-Alone Cervical IBF System | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 15 companies; a new generation was cleared every 1.0 years on median.
- 37 of the 366 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K222028 (Alphatec Spine, 2022) has gone furthest, with 28 descendants of its own.
- 9 other devices also cite its predicate K142488.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
When used as an intervertebral body fusion device, the SeaSpine Spacer System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or…
Read the full statement (2,445 words)
When used as an intervertebral body fusion device, the SeaSpine Spacer System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
The SeaSpine Cambria NanoMetalene System with NanoMetalene® surface technology is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation, such as an anterior plating system.
The SeaSpine Vu a•POD-L NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology 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 device is to be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu a•POD-L NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate. 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 non-operative treatment.
When used as an intervertebral body fusion device, the SeaSpine Vu e•POD System with NanoMetalene® surface technology 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 device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e•POD System is intended for use with supplemental fixation. Degenerative disc disease (DDD) 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 six months of non-operative treatment.
When used as a vertebral body replacement (VBR), the SeaSpine Vu e•POD System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or otherwise unstable vertebral body due to tumor or trauma (i.e., fracture). The SeaSpine Vu e•POD System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e•POD System is intended for use with supplemental internal spinal fixation.
When used with the bone screws, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology 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(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used with the SpinPlate, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device 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. These DDD patients may also have 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 composed of cancellous, cortical, and/or corticocancellous bone. When used with the SpinPlate, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, when used with the bone screws or the bone screws and the SpinPlate, is a stand-alone device. If the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is used only with the SpinPlate, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20° must also be used with additional supplemental fixation (e.g., posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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 Shoreline ACS (Anterior Cervical System) with NanoMetalene® surface technology are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of non-operative treatment.
When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).
The SeaSpine Regatta Lateral System with NanoMetalene® surface technology 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 composed of cancellous, cortical, 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.
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(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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.
The Shoreline Cervical Interbody RT System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-C7).
When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.
When used as an intervertebral body fusion device, the SeaSpine Reef TO/TA System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
The SeaSpine Reef TH System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
The SeaSpine Meridian System with NanoMetalene® surface technology 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, cortical, 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 non-operative treatment.
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(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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.
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(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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.
The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and an 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(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210497 · printed Nov 6, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210497
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026