510(k) · Cleared
Recalled · Class II · 2025Catalyft PL 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 May 24, 2021 as substantially equivalent to K171689 (Medtronic Sofamor Danek USA, Inc., 2017) and 12 other predicates after a 102-day review. Its family tree reaches back 27 generations to 1984. 1 of the 556 devices in its family, counting itself, has a Class I recall. 56 later devices descend from it. It has been recalled once.
- Decided
- May 24, 2021
- Review
- 102 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 13
Its longest line of descent runs back 27 generations to K841189 (1984). 499 ancestors in all, the oldest K792352 (1979). 56 later devices descend from it, 2 citing it directly. 1 of the 556 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 deviceK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · cites it directly · 55 of its ownK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · 2 generations on · 49 of its ownK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- Descendant · 3 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · 3 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
- Descendant · 4 generations on · 7 of its ownK240368 E3D™-A Interbody SystemEvolution Spine · 2024
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 deviceK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 56 · See all- K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021 · cites it directly55descendants
- K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022 · 2 generations on49descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 3 generations on28descendants
- K223494CD Horizon Spinal SystemMedtronic · 2023 · 3 generations on17descendants
- K240368E3D™-A Interbody SystemEvolution Spine · 2024 · 4 generations on7descendants
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) | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +1 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +2 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| +3 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +3 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| +4 | K240368 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 13 | 0 |
| 2002 | 12 | 0 |
| 2003 | 19 | 0 |
| 2004 | 29 | 0 |
| 2005 | 24 | 0 |
| 2006 | 15 | 0 |
| 2007 | 17 | 0 |
| 2008 | 50 | 1 |
| 2009 | 36 | 0 |
| 2010 | 27 | 0 |
| 2011 | 42 | 0 |
| 2012 | 29 | 0 |
| 2013 | 30 | 0 |
| 2014 | 29 | 0 |
| 2015 | 23 | 0 |
| 2016 | 17 | 0 |
| 2017 | 10 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 12 | 0 |
| 2025 | 14 | 0 |
| 2026 | 18 | 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? (13)
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 |
|---|---|---|---|
| * | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Summary page 5…ices Predicate 1 (Primary Predicate): Artic-L™ 3D Ti Spinal System and Artic-XL™ 3D Ti Spinal System (K171689, S.E. 10/05/2017; K190959, S.E. 07/03/2019) Predicate 2: Elevate™ Spin… | 2017 |
| * | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Summary page 5…(Primary Predicate): Artic-L™ 3D Ti Spinal System and Artic-XL™ 3D Ti Spinal System (K171689, S.E. 10/05/2017; K190959, S.E. 07/03/2019) Predicate 2: Elevate™ Spinal System (K142559,… | 2019 |
| * | K142559 | ELEVATE Spinal SystemSummary page 5…(K171689, S.E. 10/05/2017; K190959, S.E. 07/03/2019) Predicate 2: Elevate™ Spinal System (K142559, S.E. 06/09/2015) Predicate 3: Crescent™ Spinal System (K094025,… | 2015 |
| * | K094025 | Crescent Spinal SystemSummary page 5…Predicate 2: Elevate™ Spinal System (K142559, S.E. 06/09/2015) Predicate 3: Crescent™ Spinal System (K094025, S.E. 04/26/2010; K133216, S.E. 11/22/2013; K171031, S.E. 07/06/2017)… | 2010 |
| * | K133216 | Crescent Spinal SystemSummary page 5…S.E. 06/09/2015) Predicate 3: Crescent™ Spinal System (K094025, S.E. 04/26/2010; K133216, S.E. 11/22/2013; K171031, S.E. 07/06/2017) Predicate 4: Clydesdale™ S… | 2013 |
| * | K171031 | CRESCENT™ Spinal SystemSummary page 5…Predicate 3: Crescent™ Spinal System (K094025, S.E. 04/26/2010; K133216, S.E. 11/22/2013; K171031, S.E. 07/06/2017) Predicate 4: Clydesdale™ Spinal System (K100175, S.E… | 2017 |
| * | K100175 | Clydesdale Spinal SystemSummary page 5….E. 11/22/2013; K171031, S.E. 07/06/2017) Predicate 4: Clydesdale™ Spinal System (K100175, S.E. 06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014) Medtr… | 2010 |
| * | K132897 | Clydesdale Spinal SystemSummary page 5…K171031, S.E. 07/06/2017) Predicate 4: Clydesdale™ Spinal System (K100175, S.E. 06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014) Medtronic Navigated Manual Reus… | 2013 |
| * | K133577 | Clydesdale (R) Spinal SystemSummary page 5…Predicate 4: Clydesdale™ Spinal System (K100175, S.E. 06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014) Medtronic Navigated Manual Reusable Instruments for Use w… | 2014 |
| * | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsSummary page 5…able Instruments for Use with StealthStation™ System Navigated Elevate™ Inserter (K163581, S.E. 04/14/2017)… | 2017 |
| * | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterSummary page 6…K210425 Page 2 of 5 Navigated Capstone™ Trials (K131425, S.E. 08/14/2013; K150231, S.E. 06/16/2015) Navigated Disc Prep Instruments (K… | 2013 |
| * | K150231 | Navigated Disc Prep Instruments and CAPSTONE TrialsSummary page 6…Page 2 of 5 Navigated Capstone™ Trials (K131425, S.E. 08/14/2013; K150231, S.E. 06/16/2015) Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015, K… | 2015 |
| * | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface TechnologySummary page 6…4/2013; K150231, S.E. 06/16/2015) Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015, K163581, S.E. 04/14/2017; K201267, S.E. 08/26/2020) Description of Devices The Catalyft™ PL Expandable Interbody System… | 2020 |
What descends from it? (56)
See all 562 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2025 | Class II | Z-0580-2026 | Labeling design | Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate… |
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 · 5 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 9 months on median.
- 61 of the 499 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212524 (Medtronic Sofamor Danek USA, Inc., 2021) has gone furthest, with 55 descendants of its own.
- 4 other devices also cite its predicate K171689.
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™ PL 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-S 1 ). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved…
Read the full statement (284 words)
The Catalyft™ PL 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-S 1 ). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Additionally, the Catalyft™ PL Expandable Interbody System can be used with patients diagnosed with spinal deformities as an adjunct to fusion. 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 are intended for use with supplemental internal fixation systems.
Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems.
Navigated surgical instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.
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/K210425 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210425: Catalyft PL 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/K210425
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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