510(k) · Cleared
Recalled · Class II · 2025IB3D™ PL Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International S.A.S. (Medtronic) · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 6, 2024 as substantially equivalent to K192502 (Medtronic Sofamor Danek USA, Inc., 2020) and 2 other predicates after a 133-day review. Its family tree reaches back 27 generations to 1984. 1 of the 552 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Sep 6, 2024
- Review
- 133 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 27 generations to K841189 (1984). 550 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 552 devices in this family, counting this one, has a Class I recall.
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations between
- 3 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 2 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 1 generation backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- This deviceK241164 IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024
- Descendant · cites it directly · 0 of its ownK253577 IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic) · 2025
Show all 27 generations
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 25 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 24 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 21 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 20 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 17 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 16 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 15 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 14 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 13 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 12 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 11 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 10 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 9 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 8 generations backK160955 Tritanium® PL CageStryker · 2016
- 7 generations backK162262 Tritanium® PL CageStryker · 2016
- 6 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 5 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 4 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 3 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 2 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 1 generation backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- This deviceK241164 IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic) · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −26 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −25 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −24 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −21 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −20 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −17 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −16 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −15 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −14 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −13 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −12 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −11 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −10 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −9 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −8 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −7 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −6 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −5 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −4 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −3 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −2 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −1 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| 0 (this device) | K241164 | IB3D™ PL Spinal System | Medicrea International S.A.S. (Medtronic) | 2024 | — |
| +1 | K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 12 | 0 |
| 2002 | 15 | 0 |
| 2003 | 22 | 0 |
| 2004 | 42 | 0 |
| 2005 | 28 | 0 |
| 2006 | 19 | 0 |
| 2007 | 24 | 0 |
| 2008 | 51 | 1 |
| 2009 | 39 | 0 |
| 2010 | 30 | 0 |
| 2011 | 44 | 0 |
| 2012 | 31 | 0 |
| 2013 | 32 | 0 |
| 2014 | 34 | 0 |
| 2015 | 31 | 0 |
| 2016 | 22 | 0 |
| 2017 | 18 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Summary page 5…II III. Predicate devices Primary predicate Device name Capstone Control™ Spinal System device 510(k) information K192502, cleared on 01/22/2020 Common Name Intervertebral Fusion Device With Bone Graft, Lumbar… | 2020 |
| * | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface TechnologySummary page 5…Adaptix Interbody System with Titan nanoLOCK Surface device Technology 510(k) information K201267, cleared on 08/26/2020 Common Name Intervertebral Fusion Device With Bone Graft, Lumbar… | 2020 |
| * | K163595 | IMPIX 3D Print CagesSummary page 5…Class II Additional predicate Device name IMPIX 3D Print Cages device 510(k) information K163595, cleared on 11/13/2017 Common Name Intervertebral Fusion Device With Bone Graft, Lumbar… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2025 | Class II | Z-1038-2026 | Under Investigation by firm | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
| Oct 29, 2025 | Class II | Z-1039-2026 | Under Investigation by firm | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
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 40 years and passes through 16 companies; a new generation was cleared every 9 months on median.
- 64 of the 550 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K253577 (Medicrea International S.A.S. (Medtronic), 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K192502.
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. 2024, 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?
IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain 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 levels. When used for these indications, the IB3D™ PL Spinal System…
Read the full statement (208 words)
IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain 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 levels. When used for these indications, the IB3D™ PL Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.
All patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The IB3D™ PL Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. When implanting via posterior approach (PLIF), a minimum of two implants is required per spinal level.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241164: IB3D™ PL Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241164
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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