510(k) · Cleared
ClearedOneLIF™ Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novapproach Spine, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jun 12, 2025 as substantially equivalent to K211769 (Novapproach Spine, 2021) and 1 other predicate after a 31-day review. Its family tree reaches back 24 generations to 1984. 1 of the 406 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 12, 2025
- Review
- 31 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 24 generations to K841189 (1984). 405 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 406 devices in this family, counting this one, has a Class I recall.
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations between
- 3 generations backK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
- 2 generations backK201671 A-Link ZAcuity Surgical Devices, LLC · 2021
- 1 generation backK222561 AlignAcuity Surgical Devices, LLC · 2022
- This deviceK251459 OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC · 2025
Show all 24 generations
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 22 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 21 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 18 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 17 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 14 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 13 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 12 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 11 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 10 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 9 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 8 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 7 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 6 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 5 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 4 generations backK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- 3 generations backK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
- 2 generations backK201671 A-Link ZAcuity Surgical Devices, LLC · 2021
- 1 generation backK222561 AlignAcuity Surgical Devices, LLC · 2022
- This deviceK251459 OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC · 2025
Class I recalls in this family
- K073202 Ardis Spacer8 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −23 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −22 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −21 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −18 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −17 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −14 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −13 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −12 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −11 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −10 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −9 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −8 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −7 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −6 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −5 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
| −3 | K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 | — |
| −2 | K201671 | A-Link Z | Acuity Surgical Devices, LLC | 2021 | — |
| −1 | K222561 | Align | Acuity Surgical Devices, LLC | 2022 | — |
| 0 (this device) | 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 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 19 | 0 |
| 2004 | 28 | 0 |
| 2005 | 21 | 0 |
| 2006 | 16 | 0 |
| 2007 | 18 | 0 |
| 2008 | 50 | 1 |
| 2009 | 35 | 0 |
| 2010 | 27 | 0 |
| 2011 | 30 | 0 |
| 2012 | 21 | 0 |
| 2013 | 27 | 0 |
| 2014 | 21 | 0 |
| 2015 | 14 | 0 |
| 2016 | 10 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2021 | 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 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? (2)
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 |
|---|---|---|---|
| * | K211769 | OneLIF Intervertebral Body Replacement SystemSummary page 6…Sizes • Mechanical Performance Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Predicate Type K211769 OneLIF™ Intervertebral Body Replacement System NovApproach Spine, LLC Primary K222561 Align… | 2021 |
| * | K222561 | AlignSummary page 6…Manufacturer Predicate Type K211769 OneLIF™ Intervertebral Body Replacement System NovApproach Spine, LLC Primary K222561 Align Acuity Surgical Devices, LLC Additional PERFORMANCE DATA The OneLIF… | 2022 |
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 · 8 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 15 companies; a new generation was cleared every 1.0 years on median.
- 41 of the 405 ancestors have a recall of any class; 1 has a Class I recall.
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. 2025, 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 OneLIFT r 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 (244 words)
The OneLIFT r 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 OneLIFT r 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 200 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 200 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/K251459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251459: OneLIF™ Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251459
Report an extraction error
Are you the manufacturer?
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