510(k) · Cleared
ClearedUniVy OsteoVy Cervical IBF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vy Spine, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 4, 2022 as substantially equivalent to K202266 (Reliance Medical Systems, LLC, 2022) and 2 other predicates after a 196-day review. Its family tree reaches back 22 generations to 1984. 1 of the 279 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Nov 4, 2022
- Review
- 196 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K841189 (1984). 276 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 1 citing it directly. 1 of the 279 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK171140 Matrixx SystemNexxt Spine, LLC · 2017
- 1 generation backK202266 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2022
- This deviceK221162 UniVy OsteoVy Cervical IBF SystemVy Spine, LLC · 2022
- Descendant · cites it directly · 1 of its ownK223513 UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK241783 FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC · 2025
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 backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 4 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 2 generations backK171140 Matrixx SystemNexxt Spine, LLC · 2017
- 1 generation backK202266 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2022
- This deviceK221162 UniVy OsteoVy Cervical IBF SystemVy Spine, LLC · 2022
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView 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 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −4 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −2 | K171140 | Matrixx System | Nexxt Spine, LLC | 2017 | — |
| −1 | K202266 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2022 | — |
| 0 (this device) | K221162 | UniVy OsteoVy Cervical IBF System | Vy Spine, LLC | 2022 | — |
| +1 | K223513 | UniVy™ OsteoVy™-Ti Cervical IBF System | Vy Spine, LLC | 2023 | — |
| +2 | K241783 | FortiVy™ OsteoVy™ Lumbar IBF | Vy Spine, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 12 | 0 |
| 2002 | 10 | 0 |
| 2003 | 17 | 0 |
| 2004 | 26 | 0 |
| 2005 | 17 | 0 |
| 2006 | 10 | 0 |
| 2007 | 14 | 0 |
| 2008 | 38 | 1 |
| 2009 | 23 | 0 |
| 2010 | 14 | 0 |
| 2011 | 19 | 0 |
| 2012 | 13 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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.
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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | K202266 | Reliance Cervical IBF SystemSummary page 4…ivalence: The subject UniVy™ OsteoVy™ Cervical IBF System is substantially equivalent to the legally marketed primary predicate device, the Reliance Cervical IBF System (K202266) and the secondary predicate devices, Nexxt Spine Matrixx™ System (K171140) and Vy Spine ClariVy™ Cervical IBF System (K212715).… | 2022 |
| * | K171140 | Matrixx SystemSummary page 4…equivalent to the legally marketed primary predicate device, the Reliance Cervical IBF System (K202266) and the secondary predicate devices, Nexxt Spine Matrixx™ System (K171140) and Vy Spine ClariVy™ Cervical IBF System (K212715). The subject UniVy™ OsteoVy™ Cervical IBF System is equivalent to its commer… | 2017 |
| * | K212715 | Vy Spine ClariVy Cervical IBF SystemSummary page 4…device, the Reliance Cervical IBF System (K202266) and the secondary predicate devices, Nexxt Spine Matrixx™ System (K171140) and Vy Spine ClariVy™ Cervical IBF System (K212715). The subject UniVy™ OsteoVy™ Cervical IBF System is equivalent to its commercially available predicate in terms of intended use,… | 2021 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223513 | UniVy™ OsteoVy™-Ti Cervical IBF System | 2023 | 1 |
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 · 5 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 10 months on median.
- 39 of the 276 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K223513 (Vy Spine, LLC, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The UniVy™ OsteoVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The UniVy™ OsteoVy™ Cervical IBF System is intended for use at one level…
Read the full statement (126 words)
The UniVy™ OsteoVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The UniVy™ OsteoVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The UniVy™ OsteoVy™ Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221162: UniVy OsteoVy Cervical IBF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221162
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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