510(k) · Cleared
ClearedCatalyft™ 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. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Oct 28, 2024 as substantially equivalent to K212653 (Medtronic Sofamor Danek USA, Inc., 2021) and 4 other predicates after a 112-day review. Its family tree reaches back 22 generations to 1984.
- Decided
- Oct 28, 2024
- Review
- 112 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 22 generations to K841189 (1984). 280 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK170592 NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 2017
- 2 generations backK172328 SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2017
- 1 generation backK212653 Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- This deviceK241992 Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2024
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 4 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK170592 NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 2017
- 2 generations backK172328 SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2017
- 1 generation backK212653 Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- This deviceK241992 Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −4 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K170592 | NuVasive BASE Interfixated Titanium System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K172328 | SOVEREIGN™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| −1 | K212653 | Catalyft LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 7 |
| 0 (this device) | K241992 | Catalyft™ LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2024 | — |
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 | 22 | 0 |
| 2010 | 19 | 0 |
| 2011 | 18 | 0 |
| 2012 | 11 | 0 |
| 2013 | 13 | 0 |
| 2014 | 11 | 0 |
| 2015 | 8 | 0 |
| 2016 | 3 | 0 |
| 2017 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 5…es OVD (888.3080) Predicate 1 (Primary Predicate): Catalyft™ LS Expandable Interbody System (K212653, S.E. 11/19/2021) Predicate 2: SOVEREIGN™ Spinal System (K091813, S.E.… | 2021 |
| * | K091813 | Intrepid Spinal SystemSummary page 5…Catalyft™ LS Expandable Interbody System (K212653, S.E. 11/19/2021) Predicate 2: SOVEREIGN™ Spinal System (K091813, S.E. 11/17/2009) Predicate Devices Predicate 3: Crescent™ PEEK… | 2009 |
| * | K094025 | Crescent Spinal SystemSummary page 5…te 2: SOVEREIGN™ Spinal System (K091813, S.E. 11/17/2009) Predicate Devices Predicate 3: Crescent™ PEEK (K094025, S.E. 04/26/2010) Predicate 4: Clydesdale™ Spinal System (K132897, S.E.… | 2010 |
| * | K132897 | Clydesdale Spinal SystemSummary page 5…ate Devices Predicate 3: Crescent™ PEEK (K094025, S.E. 04/26/2010) Predicate 4: Clydesdale™ Spinal System (K132897, S.E. 12/11/2013) Predicate 5: Elevate™ Spinal System (K142559, S.… | 2013 |
| * | K142559 | ELEVATE Spinal SystemSummary page 5…Predicate 4: Clydesdale™ Spinal System (K132897, S.E. 12/11/2013) Predicate 5: Elevate™ Spinal System (K142559, S.E. 06/09/2015) Medtronic – Confidential… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 12 companies; a new generation was cleared every 11 months on median.
- 25 of the 280 ancestors have a recall of any class.
- 1 other device also cites its predicate K212653.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
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 approaches.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241992: Catalyft™ LS Expandable Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241992
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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