510(k) · Cleared
ClearedCrescent (R) Spinal System Titanium
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 Aug 9, 2011 as substantially equivalent to K094025 (Medtronic Sofamor Danek, 2010) and 2 other predicates after a 165-day review. Its family tree reaches back 11 generations to 1984. 1 of the 849 devices in its family, counting itself, has a Class I recall. 808 later devices descend from it.
- Decided
- Aug 9, 2011
- Review
- 165 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K841189 (1984). 40 ancestors in all. 808 later devices descend from it, 7 citing it directly. 1 of the 849 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 1 generation backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- This deviceK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · cites it directly · 723 of its ownK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 2 generations on · 709 of its ownK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- Descendant · cites it directly · 682 of its ownK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- Descendant · 2 generations on · 676 of its ownK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- Descendant · 3 generations on · 645 of its ownK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 1 generation backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- This deviceK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
Showing 5 of 808 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 808 · See all- K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · cites it directly723descendants
- K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013 · 2 generations on709descendants
- K121683Acculif TL CageCoalign Innovations, Inc. · 2012 · cites it directly682descendants
- K123752Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · 2 generations on676descendants
- K132505Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · 3 generations on645descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −1 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| 0 (this device) | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +1 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +2 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +1 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| +2 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| +3 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 8 | 0 |
| 2014 | 12 | 0 |
| 2015 | 15 | 0 |
| 2016 | 31 | 0 |
| 2017 | 54 | 0 |
| 2018 | 60 | 0 |
| 2019 | 72 | 0 |
| 2020 | 82 | 0 |
| 2021 | 71 | 1 |
| 2022 | 73 | 0 |
| 2023 | 91 | 0 |
| 2024 | 93 | 0 |
| 2025 | 76 | 0 |
| 2026 | 68 | 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? (4)
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 |
|---|---|---|---|
| * | K094025 | Crescent Spinal SystemSummary page 2…cations for use for the subject CRESCENT® Spinal System Titanium are substantially equivalent to the following predicates: " CRESCENT® Spinal System K094025 " LT-CAGE® Titanium Lumbar Tapered Fusion Device P9710015/S0lO " CLYDESDALE® Spinal System K100175… | 2010 |
| Kept off the family tree | P9710015 | LT-CAGE® Titanium Lumbar Tapered Fusion Device Number could not be read Summary page 2…ium are substantially equivalent to the following predicates: " CRESCENT® Spinal System K094025 " LT-CAGE® Titanium Lumbar Tapered Fusion Device P9710015/S0lO " CLYDESDALE® Spinal System K100175 " CAPSTONE® Spinal System K073291 IX. Discussion of Non-Clinic… | |
| * | K100175 | Clydesdale Spinal SystemSummary page 2…icates: " CRESCENT® Spinal System K094025 " LT-CAGE® Titanium Lumbar Tapered Fusion Device P9710015/S0lO " CLYDESDALE® Spinal System K100175 " CAPSTONE® Spinal System K073291 IX. Discussion of Non-Clinical Testing: The subject Intervertebral Body F… | 2010 |
| * | K073291 | Capstone Spinal SystemSummary page 2…K094025 " LT-CAGE® Titanium Lumbar Tapered Fusion Device P9710015/S0lO " CLYDESDALE® Spinal System K100175 " CAPSTONE® Spinal System K073291 IX. Discussion of Non-Clinical Testing: The subject Intervertebral Body Fusion Devices were tested using Finite Element… | 2008 |
What descends from it? (808)
See all 8087 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121760 | Capstone Spinal System | 2012 | 723 |
| K121683 | Acculif TL Cage | 2012 | 682 |
| K171031 | CRESCENT™ Spinal System | 2017 | 144 |
| K133216 | Crescent Spinal System | 2013 | 92 |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT… | 2017 | 6 |
| K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System… | 2020 | 4 |
| K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT… | 2020 | 0 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 40 ancestors have a recall of any class.
- Of its descendants, K121760 (Medtronic Sofamor Danek USA, Inc., 2012) has gone furthest, with 723 descendants of its own.
- 19 other devices also cite its predicate K094025.
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. 2011, 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 CRESCENT® Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally…
Read the full statement (115 words)
The CRESCENT® Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110543 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110543: Crescent (R) Spinal System Titanium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110543
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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