510(k) · Cleared
ClearedCatalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
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 Dec 16, 2022 as substantially equivalent to K212653 (Medtronic Sofamor Danek USA, Inc., 2021) and 8 other predicates after a 71-day review. Its family tree reaches back 30 generations to 1984. 1 of the 603 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 16, 2022
- Review
- 71 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 30 generations to K841189 (1984). 602 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 603 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 backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 2 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- This deviceK223153 Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface…Medtronic Sofamor Danek USA, Inc. · 2022
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 backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 2 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- This deviceK223153 Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface…Medtronic Sofamor Danek USA, Inc. · 2022
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
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 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −2 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −1 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| 0 (this device) | 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 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 9 | 0 |
| 2001 | 14 | 0 |
| 2002 | 16 | 0 |
| 2003 | 22 | 0 |
| 2004 | 41 | 0 |
| 2005 | 33 | 0 |
| 2006 | 17 | 0 |
| 2007 | 19 | 0 |
| 2008 | 54 | 1 |
| 2009 | 39 | 0 |
| 2010 | 28 | 0 |
| 2011 | 45 | 0 |
| 2012 | 30 | 0 |
| 2013 | 34 | 0 |
| 2014 | 35 | 0 |
| 2015 | 32 | 0 |
| 2016 | 21 | 0 |
| 2017 | 21 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 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? (9)
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 |
|---|---|---|---|
| * | K212653 | Catalyft LS Expandable Interbody SystemSummary page 4…80) OVD (888.3080) Predicate 1 (Primary Predicate): Catalyft™ LS Expandable Interbody System (K212653, S.E. 11/19/2021) Predicate 2: Anteralign LS™ Interbody System with Titan Predicate Devices nano… | 2021 |
| * | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface TechnologySummary page 4…ystem (K212653, S.E. 11/19/2021) Predicate 2: Anteralign LS™ Interbody System with Titan Predicate Devices nanoLOCK™ Surface Technology (K214010, S.E. 04/12/2022) Predicate 3: Crescent™ PEEK (K094025, S.E. 04/26/2010; K1332… | 2022 |
| * | K094025 | Crescent Spinal SystemSummary page 4…n LS™ Interbody System with Titan Predicate Devices nanoLOCK™ Surface Technology (K214010, S.E. 04/12/2022) Predicate 3: Crescent™ PEEK (K094025, S.E. 04/26/2010; K133216, S.E. 11/22/2013; K171031, S.E. 07/06/2017) Predicat… | 2010 |
| * | K133216 | Crescent Spinal SystemSummary page 4…es nanoLOCK™ Surface Technology (K214010, S.E. 04/12/2022) Predicate 3: Crescent™ PEEK (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. ===… | 2013 |
| * | K171031 | CRESCENT™ Spinal SystemSummary page 4…Technology (K214010, S.E. 04/12/2022) Predicate 3: Crescent™ PEEK (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 4…(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. K223153- Page 2 of 4 06… | 2010 |
| * | K132897 | Clydesdale Spinal SystemSummary page 5…esdale™ Spinal System (K100175, S.E. K223153- Page 2 of 4 06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014) Predicate 5: Elevate™ Spinal System (K142559, S.E. 06/09/2015)… | 2013 |
| * | K133577 | Clydesdale (R) Spinal SystemSummary page 5…0175, S.E. K223153- Page 2 of 4 06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014) Predicate 5: Elevate™ Spinal System (K142559, S.E. 06/09/2015) The Catalyft™ LS Expand… | 2014 |
| * | K142559 | ELEVATE Spinal SystemSummary page 5…K223153- Page 2 of 4 06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014) Predicate 5: Elevate™ Spinal System (K142559, S.E. 06/09/2015) The Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technolo… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 71 of the 602 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K212653.
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 Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textured features, 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…
Read the full statement (275 words)
The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textured features, 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 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 anterior or oblique approach.
The Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable Interbody System device is intended to be used with 4 titanium alloy screws. 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/K223153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223153: Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223153
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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