510(k) · Cleared
ClearedVusion (R) OS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 25, 2011 as substantially equivalent to K062666 (Ortho Development Corp., 2007) and 2 other predicates after a 106-day review. Its family tree reaches back 9 generations to 1984. 1 of the 20 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 25, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K841189 (1984). 19 ancestors in all. No later device cites it as a predicate yet. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 2 generations backK071031 VU E*Pod Vertebral Body ReplacementTheken Spine, LLC · 2007
- 1 generation backK082712 Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC · 2009
- This deviceK111965 Vusion (R) OSOrtho Development · 2011
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 3 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 2 generations backK071031 VU E*Pod Vertebral Body ReplacementTheken Spine, LLC · 2007
- 1 generation backK082712 Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC · 2009
- This deviceK111965 Vusion (R) OSOrtho Development · 2011
Class I recalls in this family
- K073202 Ardis Spacerdirect predicate · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −3 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| −2 | K071031 | VU E*Pod Vertebral Body Replacement | Theken Spine, LLC | 2007 | — |
| −1 | K082712 | Theken Spine VU Epod and VU Lpod System | Theken Spine, LLC | 2009 | — |
| 0 (this device) | K111965 | Vusion (R) OS | Ortho Development | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 1 |
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? (3)
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 |
|---|---|---|---|
| * | K062666 | Vusion TS, PS, and CS Partial Vertebral Body ReplacementsSummary page 1…Device CLASSIFICATION: 21 CFR888.3080, Intervertebral Body Fusion Device. DEVICE PRODUCT CODE: MAX PREDICATE DEVICES: Vusiont TS, PS, and CS Partial VBR (K062666) Ortho Development Corp VUTM ePOD& Vu TM LPOD (K082712) The… | 2007 |
| * | K082712 | Theken Spine VU Epod and VU Lpod SystemSummary page 1…: MAX PREDICATE DEVICES: Vusiont TS, PS, and CS Partial VBR (K062666) Ortho Development Corp VUTM ePOD& Vu TM LPOD (K082712) The ken Spine, LLW Ardis' Spacer (K(073202) Abbott Spine I… | 2009 |
| * | K073202 | Ardis SpacerSummary page 1…Ortho Development Corp VUTM ePOD& Vu TM LPOD (K082712) The ken Spine, LLW Ardis' Spacer (K(073202) Abbott Spine Inc. Vusion@510(k) Page 1 of 3 Section 5,5S10(k) Su… | 2008 |
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 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
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?
Vusion OS is indicated for use as an interbody fusion device at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Vusion OS is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111965: Vusion (R) OS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111965
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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