510(k) · Cleared
ClearedWaveForm A Interbody 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 Nov 7, 2022 as substantially equivalent to K210583 (SeaSpine Orthopedics Corporation, 2021) and 2 other predicates after a 59-day review. Its family tree reaches back 30 generations to 1984. 1 of the 564 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Nov 7, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 30 generations to K841189 (1984). 554 ancestors in all, the oldest K792352 (1979). 9 later devices descend from it, 2 citing it directly. 1 of the 564 devices in this family, counting this one, has a Class I recall.
- Root · 30 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations between
- 3 generations backK201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2020
- 2 generations backK210583 SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation · 2021
- 1 generation backK220711 SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation · 2022
- This deviceK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
- Descendant · cites it directly · 8 of its ownK233694 Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024
- Descendant · 2 generations on · 3 of its ownK241466 Shoreline ACS Interbody System; Shoreline RT Interbody System…SeaSpine Orthopedics Corporation · 2024
- Descendant · 2 generations on · 2 of its ownK240830 Reef TO/TA System; Regatta Lateral System; Explorer TO System…Orthofix Medical, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK250987 aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta…SeaSpine Orthopedics Corporation · 2026
Show all 30 generations
- Root · 30 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 29 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 28 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 27 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 26 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 25 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 24 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 23 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 22 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 21 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 20 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 19 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 18 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 17 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 16 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 15 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 14 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 13 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 12 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 11 generations backK160955 Tritanium® PL CageStryker · 2016
- 10 generations backK162262 Tritanium® PL CageStryker · 2016
- 9 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 8 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 7 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 6 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 5 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 4 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 3 generations backK201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2020
- 2 generations backK210583 SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation · 2021
- 1 generation backK220711 SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation · 2022
- This deviceK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 5 of 9 · See all- K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024 · cites it directly8descendants
- K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation · 2024 · 2 generations on3descendants
- K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc. · 2024 · 2 generations on2descendants
- K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc. · 2025 · 3 generations on1descendant
- K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −30 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −29 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −28 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −27 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −26 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −25 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −24 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −23 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −22 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −21 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −20 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −19 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −18 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −17 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −16 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −15 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −14 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −13 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −12 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −11 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −10 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −9 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −8 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −7 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −6 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −5 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −4 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −3 | K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2020 | — |
| −2 | K210583 | SeaSpine WaveForm™ A Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
| −1 | K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | SeaSpine Orthopedics Corporation | 2022 | — |
| 0 (this device) | K222732 | WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2022 | — |
| +1 | K233694 | Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2024 | — |
| +2 | K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral… | SeaSpine Orthopedics Corporation | 2024 | — |
| +2 | K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C… | Orthofix Medical, Inc. | 2024 | — |
| +3 | K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. | 2025 | — |
| +3 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… | SeaSpine Orthopedics Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 11 | 0 |
| 2002 | 14 | 0 |
| 2003 | 20 | 0 |
| 2004 | 41 | 0 |
| 2005 | 30 | 0 |
| 2006 | 16 | 0 |
| 2007 | 21 | 0 |
| 2008 | 53 | 1 |
| 2009 | 43 | 0 |
| 2010 | 32 | 0 |
| 2011 | 46 | 0 |
| 2012 | 31 | 0 |
| 2013 | 29 | 0 |
| 2014 | 33 | 0 |
| 2015 | 26 | 0 |
| 2016 | 25 | 0 |
| 2017 | 16 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K210583 | SeaSpine WaveForm™ A Interbody SystemSummary page 5…Trade Name(s) Manufacturer Primary Predicate Device SeaSpine K210583 MAX, OVD WaveForm A Interbody System Orthopedics… | 2021 |
| * | K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSummary page 5…Corporation Additional Predicate Device(s) SeaSpine K220711 MAX, OVD Meridian System Orthopedics… | 2022 |
| * | K213420 | WaveForm L System, WaveForm TO System, WaveForm TA SystemSummary page 5…Corporation WaveForm L Interbody System, SeaSpine K213420 MAX, PHM WaveForm TO Interbody System, Orthopedics WaveForm TA In… | 2022 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 16 companies; a new generation was cleared every 8 months on median.
- 61 of the 554 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K233694 (SeaSpine Orthopedics Corporation, 2024) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K210583.
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. 2022, 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?
Interbody Device (IBD) Implants (i.e., interbody implants used alone): The SeaSpine WaveForm A System Interbody, when used with or without a Spin Plate, 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…
Read the full statement (595 words)
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine WaveForm A System Interbody, when used with or without a Spin Plate, 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 WaveForm A 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.
No-profile Implants w/ Screws:
The SeaSpine WaveForm A System No-profile Interbody, when used with Screws and with or without 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 (greater than 20 degrees) are intended for use with supplemental fixation.
No-profile Implants w/ Inline Fixation Anchors:
The SeaSpine WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with 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 WaveForm A Noprofile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine WaveForm A System Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, 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 (greater than 20 degrees) are intended for use with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222732 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222732: WaveForm A Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222732
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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