510(k) · Cleared
Recalled · Class II · 2023Catalyft LS Expandable Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 19, 2021 as substantially equivalent to K172328 (Medtronic Sofamor Danek USA, Inc., 2017) and 1 other predicate after an 88-day review. Its family tree reaches back 21 generations to 1984. 2 later devices descend from it. It has been recalled 7 times.
- Decided
- Nov 19, 2021
- Review
- 88 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 7
- Predicates
- 7
Its longest line of descent runs back 21 generations to K841189 (1984). 276 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK170592 NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 2017
- 1 generation backK172328 SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2017
- This deviceK212653 Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK241992 Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK223153 Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface…Medtronic Sofamor Danek USA, Inc. · 2022
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 4 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK170592 NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 2017
- 1 generation backK172328 SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2017
- This deviceK212653 Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021
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 |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −11 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −10 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −9 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −8 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −7 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −6 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −5 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −4 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −2 | K170592 | NuVasive BASE Interfixated Titanium System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K172328 | SOVEREIGN™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| 0 (this device) | K212653 | Catalyft LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +1 | K241992 | Catalyft™ LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2024 | — |
| +1 | K223153 | Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 16 | 0 |
| 2004 | 25 | 0 |
| 2005 | 15 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 37 | 0 |
| 2009 | 21 | 0 |
| 2010 | 19 | 0 |
| 2011 | 18 | 0 |
| 2012 | 10 | 0 |
| 2013 | 13 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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.
Planning a device in MAX? 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K172328 | SOVEREIGN™ Spinal SystemSummary page 5…0) Product Codes OVD (888.3080) Predicate 1 (Primary Predicate) – SOVEREIGN™ Spinal System (K172328, S.E 11/02/2017) and (K091813, S.E 11/17/2009). 3UHGLFDWHௗ–ௗ%$6(ௗ,QWHUIL[DW… | 2017 |
| * | K091813 | Intrepid Spinal SystemSummary page 5…OVD (888.3080) Predicate 1 (Primary Predicate) – SOVEREIGN™ Spinal System (K172328, S.E 11/02/2017) and (K091813, S.E 11/17/2009). 3UHGLFDWHௗ–ௗ%$6(ௗ,QWHUIL[DWHGௗ7LWDQLXPௗ .6( Pre… | 2009 |
| Kept off the family tree | K201820 | FDA’s K201820 is NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2020 |
| Kept off the family tree | K094025 | FDA’s K094025 is Crescent Spinal System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| Kept off the family tree | K142559 | FDA’s K142559 is ELEVATE Spinal System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2015 |
| Kept off the family tree | K132897 | FDA’s K132897 is Clydesdale Spinal System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2013 |
| Kept off the family tree | K210425 | FDA’s K210425 is Catalyft PL Expandable Interbody System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2021 |
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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2023 | Class II | Z-2118-2023 | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give… |
| Jun 6, 2023 | Class II | Z-2117-2023 | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give… |
| Jun 6, 2023 | Class II | Z-2119-2023 | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give… |
| Jun 6, 2023 | Class II | Z-2122-2023 | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give… |
| Jun 6, 2023 | Class II | Z-2121-2023 | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give… |
| Jun 6, 2023 | Class II | Z-2120-2023 | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give… |
| Jun 6, 2023 | Class II | Z-2123-2023 | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 12 companies; a new generation was cleared every 10 months on median.
- 24 of the 276 ancestors have a recall of any class.
- Of its descendants, K241992 (Medtronic Sofamor Danek USA, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K172328.
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?
The Catalyft™ LS Expandable Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™ LS Expandable Interbody System can be used with patients diagnosed with spinal…
Read the full statement (249 words)
The Catalyft™ LS Expandable Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™ LS Expandable Interbody System can be used with patients diagnosed with spinal multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g posterior fixation) must be used. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and or oblique approach.
The Catalyft™ LS Expandable interbody system cages used with 4 titanium alloy screws may be used as a stand-alone device up to 20°lordosis. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and supplemental fixation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212653 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212653: Catalyft LS Expandable 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/K212653
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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