510(k) · Cleared
Recalled · Class II · 2026OneLIF Intervertebral Body Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novapproach Spine · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Sep 7, 2021 as substantially equivalent to K150135 (Medtronic Sofamor Danek USA, Inc., 2015) and 2 other predicates after a 91-day review. Its family tree reaches back 20 generations to 1984. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Sep 7, 2021
- Review
- 91 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 20 generations to K841189 (1984). 306 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK170592 NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 2017
- This deviceK211769 OneLIF Intervertebral Body Replacement SystemNovapproach Spine · 2021
- Descendant · cites it directly · 0 of its ownK251459 OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC · 2025
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK170592 NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 2017
- This deviceK211769 OneLIF Intervertebral Body Replacement SystemNovapproach Spine · 2021
Most influential descendants
Showing 1 of 1 · See all- K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −5 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −3 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −2 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −1 | K170592 | NuVasive BASE Interfixated Titanium System | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K211769 | OneLIF Intervertebral Body Replacement System | Novapproach Spine | 2021 | — |
| +1 | K251459 | OneLIF™ Interbody Fusion System | Novapproach Spine, LLC | 2025 | — |
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 | 17 | 0 |
| 2004 | 26 | 0 |
| 2005 | 19 | 0 |
| 2006 | 11 | 0 |
| 2007 | 17 | 0 |
| 2008 | 43 | 0 |
| 2009 | 26 | 0 |
| 2010 | 20 | 0 |
| 2011 | 21 | 0 |
| 2012 | 11 | 0 |
| 2013 | 18 | 0 |
| 2014 | 12 | 0 |
| 2015 | 8 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (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 |
|---|---|---|---|
| * | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemSummary page 5…Trade or Proprietary or Manufacturer Predicate Model Name Type K150135 DIVERGENCE™ Medtronic Sofamor Primary Anterior/Oblique… | 2015 |
| * | K170592 | NuVasive BASE Interfixated Titanium SystemSummary page 5…ENCE™ Medtronic Sofamor Primary Anterior/Oblique Lumbar Danek USA Fusion System K170592 BASE Interfixated Titanium NuVasive Additional System K1808… | 2017 |
| * | K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar SystemSummary page 5…Fusion System K170592 BASE Interfixated Titanium NuVasive Additional System K180814 M3™ Stand-Alone Anterior CoreLink Additional Lumbar System… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251459 | OneLIF™ Interbody Fusion System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2026 | Class II | Z-2213-2026 | Process design | Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to… |
| Oct 12, 2022 | Class II | Z-0246-2023 | Nonconforming Material/Component | The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 30 of the 306 ancestors have a recall of any class.
- Of its descendants, K251459 (Novapproach Spine, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K150135.
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. 2021, 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 OneLIF™ Interbody Fusion System is an interbody fusion device system indicated for use in skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1), in patients with the following indications: degenerative disc disease (DDD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, spinal deformity (degenerative scoliosis or kyphosis), spondylolisthesis or retrolisthesis, and…
Read the full statement (243 words)
The OneLIF™ Interbody Fusion System is an interbody fusion device system indicated for use in skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1), in patients with the following indications: degenerative disc disease (DDD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, spinal deformity (degenerative scoliosis or kyphosis), spondylolisthesis or retrolisthesis, and failed previous fusion (pseudoarthrosis). Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
The OneLIF™ Interbody Fusion System is intended to be used with or without the screws which accompany the implants. These devices are intended for stand-alone use in patients with DDD or degenerative spondylolisthesis at one or two contiguous levels only when used with at least three screws per implant (including at least one screw in each endplate) and when ≤ 20° lordotic implants are used. When used at more than 2 contiguous levels, or for treatment of conditions other than DDD or degenerative spondylolisthesis, or with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.
The implants can be placed via a variety of open or minimally invasive approaches. These include anterior and oblique approaches. The implant is designed for use with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211769: OneLIF Intervertebral Body Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211769
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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