510(k) · Cleared
Clearedrestor3d TiDAL Lumbar Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restor3D · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 17, 2022 as substantially equivalent to K201755 (SeaSpine Orthopedics Corporation, 2020) and 7 other predicates after a 114-day review. Its family tree reaches back 29 generations to 1984. 1 of the 553 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jun 17, 2022
- Review
- 114 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 29 generations to K841189 (1984). 550 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly. 1 of the 553 devices in this family, counting this one, has a Class I recall.
- Root · 29 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations between
- 3 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 2 generations backK201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2020
- 1 generation backK210583 SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation · 2021
- This deviceK220523 restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 2022
- Descendant · cites it directly · 0 of its ownK234087 restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D · 2024
- Descendant · cites it directly · 0 of its ownK223326 Axiom PSR SystemRestor3D · 2023 · Recalled
Show all 29 generations
- Root · 29 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 28 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 27 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 26 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 25 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 24 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 23 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 22 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 21 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 20 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 19 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 18 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 17 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 16 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 15 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 14 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 13 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 12 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 11 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 10 generations backK160955 Tritanium® PL CageStryker · 2016
- 9 generations backK162262 Tritanium® PL CageStryker · 2016
- 8 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 7 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 6 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 5 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 4 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 3 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 2 generations backK201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2020
- 1 generation backK210583 SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation · 2021
- This deviceK220523 restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 2022
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −29 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −28 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −27 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −26 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −25 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −24 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −23 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −22 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −21 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −20 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −19 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −18 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −17 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −16 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −15 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −14 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −13 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −12 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −11 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −10 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −9 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −8 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −7 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −6 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −5 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −4 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −3 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −2 | K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2020 | — |
| −1 | K210583 | SeaSpine WaveForm™ A Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
| 0 (this device) | K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | Restor3D | 2022 | — |
| +1 | K234087 | restor3d TIDAL Lumbar Interbody Fusion System | Restor3D | 2024 | — |
| +1 | K223326 | Axiom PSR System | Restor3D | 2023 | 1 |
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 | 20 | 0 |
| 2004 | 40 | 0 |
| 2005 | 30 | 0 |
| 2006 | 16 | 0 |
| 2007 | 20 | 0 |
| 2008 | 53 | 1 |
| 2009 | 43 | 0 |
| 2010 | 32 | 0 |
| 2011 | 46 | 0 |
| 2012 | 32 | 0 |
| 2013 | 29 | 0 |
| 2014 | 33 | 0 |
| 2015 | 27 | 0 |
| 2016 | 26 | 0 |
| 2017 | 16 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (8)
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 |
|---|---|---|---|
| * | K201755 | WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSummary page 5…uivalent to the following devices: 510(k) Trade Name Manufacturer Primary Predicate Device K201755 Waveform (L, TO, TA, A) Seaspine… | 2020 |
| * | K210583 | SeaSpine WaveForm™ A Interbody SystemSummary page 5…imary Predicate Device K201755 Waveform (L, TO, TA, A) Seaspine K210583 Interbody System Additional Predicate Device K162496 K180556 F3d Interbody… | 2021 |
| * | K162496 | Foundation 3D InterbodySummary page 5…Seaspine K210583 Interbody System Additional Predicate Device K162496 K180556 F3d Interbody System Corelink K183239 K170851… | 2017 |
| * | K180556 | Corelink Foundation 3D Anterior Lumbar SystemSummary page 5…Seaspine K210583 Interbody System Additional Predicate Device K162496 K180556 F3d Interbody System Corelink K183239 K170851… | 2018 |
| * | K183239 | CoreLink F3D™ Lateral SystemSummary page 5…Interbody System Additional Predicate Device K162496 K180556 F3d Interbody System Corelink K183239 K170851 Anterior Spine Truss System K153436… | 2018 |
| * | K170851 | Anterior Spine Truss System (STS) Interbody Fusion DeviceSummary page 5…tem Additional Predicate Device K162496 K180556 F3d Interbody System Corelink K183239 K170851 Anterior Spine Truss System K153436… | 2017 |
| * | K153436 | LATERAL Spine Truss SystemSummary page 5…F3d Interbody System Corelink K183239 K170851 Anterior Spine Truss System K153436 4web Interbody Fusion Device K14… | 2016 |
| * | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)Summary page 5…terior Spine Truss System K153436 4web Interbody Fusion Device K143258 F. Device Description: The restor3d TiDAL Lumbar Interbody Fusion System are additively manufactured Titanium All… | 2015 |
What descends from it? (2)
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 · 3 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 17 companies; a new generation was cleared every 8 months on median.
- 59 of the 550 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K234087 (Restor3D, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K201755.
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?
The restor3d lumbar cages are intended to be used as an intervertebral body fusion device with bone graft for use in lumbar spine. They are indicated for use in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels from L2-S1. DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis…
Read the full statement (143 words)
The restor3d lumbar cages are intended to be used as an intervertebral body fusion device with bone graft for use in lumbar spine. They are indicated for use in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels from L2-S1. DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Implants are used to facilitate fusion in the lumbar spine using autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbar spine.
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/K220523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220523: restor3d TiDAL Lumbar Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220523
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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