510(k) · Cleared
ClearedReliance Lumbar IBF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliance Medical Systems · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jan 9, 2019 as substantially equivalent to K113540 (Reliance Medical Systems, LLC, 2012) and 6 other predicates after a 257-day review. Its family tree reaches back 15 generations to 1984.
- Decided
- Jan 9, 2019
- Review
- 257 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K841189 (1984). 121 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK113642 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA · 2012
- 2 generations backK121982 Sovereign Spinal SystemMedtronic Sofamor Danek · 2012
- 1 generation backK131276 Lateral SynfixSynthes (USA) Products, LLC · 2014
- This deviceK181118 Reliance Lumbar IBF SystemReliance Medical Systems · 2019
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 4 generations backK111525 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2011
- 3 generations backK113642 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA · 2012
- 2 generations backK121982 Sovereign Spinal SystemMedtronic Sofamor Danek · 2012
- 1 generation backK131276 Lateral SynfixSynthes (USA) Products, LLC · 2014
- This deviceK181118 Reliance Lumbar IBF SystemReliance Medical Systems · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −4 | K111525 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2011 | — |
| −3 | K113642 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek USA | 2012 | — |
| −2 | K121982 | Sovereign Spinal System | Medtronic Sofamor Danek | 2012 | — |
| −1 | K131276 | Lateral Synfix | Synthes (USA) Products, LLC | 2014 | — |
| 0 (this device) | K181118 | Reliance Lumbar IBF System | Reliance Medical Systems | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 13 | 0 |
| 2005 | 8 | 0 |
| 2006 | 1 | 0 |
| 2007 | 8 | 0 |
| 2008 | 16 | 0 |
| 2009 | 8 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2016 | 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? (7)
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 |
|---|---|---|---|
| * | K113540 | Reliance Lumbar Ibf SystemSummary page 4…OVD, MAX Substantial Equivalence The Reliance Lumbar IBF is substantially equivalent to the legally marketed primary predicate Reliance Lumbar IBF (K113540, K160463) and to the secondary predicate devices Globus Intercontinental Plate-Spacer (K103382), Globus Independence Spacer (K120… | 2012 |
| * | K160463 | Reliance Lumbar IBF SystemSummary page 4…OVD, MAX Substantial Equivalence The Reliance Lumbar IBF is substantially equivalent to the legally marketed primary predicate Reliance Lumbar IBF (K113540, K160463) and to the secondary predicate devices Globus Intercontinental Plate-Spacer (K103382), Globus Independence Spacer (K120101), K2M… | 2016 |
| * | K103382 | Intercontinental Plate-SpacerSummary page 4…equivalent to the legally marketed primary predicate Reliance Lumbar IBF (K113540, K160463) and to the secondary predicate devices Globus Intercontinental Plate-Spacer (K103382), Globus Independence Spacer (K120101), K2M Chesapeake System (120031), Lanx Fusion System (K131547) and Synthes SynFix (K131276)… | 2011 |
| * | K120101 | Independence SpacerSummary page 4…imary predicate Reliance Lumbar IBF (K113540, K160463) and to the secondary predicate devices Globus Intercontinental Plate-Spacer (K103382), Globus Independence Spacer (K120101), K2M Chesapeake System (120031), Lanx Fusion System (K131547) and Synthes SynFix (K131276). The Reliance Lumbar IBF is equivalen… | 2012 |
| * | K120031 | Chesapeake Spinal SystemSummary page 4…BF (K113540, K160463) and to the secondary predicate devices Globus Intercontinental Plate-Spacer (K103382), Globus Independence Spacer (K120101), K2M Chesapeake System (120031), Lanx Fusion System (K131547) and Synthes SynFix (K131276). The Reliance Lumbar IBF is equivalent to these commercially availabl… | 2012 |
| * | K131547 | Lanx Fusion SystemSummary page 4…the secondary predicate devices Globus Intercontinental Plate-Spacer (K103382), Globus Independence Spacer (K120101), K2M Chesapeake System (120031), Lanx Fusion System (K131547) and Synthes SynFix (K131276). The Reliance Lumbar IBF is equivalent to these commercially available devices in terms of material… | 2013 |
| * | K131276 | Lateral SynfixSummary page 4…es Globus Intercontinental Plate-Spacer (K103382), Globus Independence Spacer (K120101), K2M Chesapeake System (120031), Lanx Fusion System (K131547) and Synthes SynFix (K131276). The Reliance Lumbar IBF is equivalent to these commercially available devices in terms of material, intended use, levels of att… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 12 companies; a new generation was cleared every 1.4 years on median.
- 15 of the 121 ancestors have a recall of any class.
- 3 other devices also cite its predicate K113540.
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. 2019, 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 Reliance LXPEDU IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems 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. Additional supplemental fixation is not necessary for the Lumbar IBF-S if the…
Read the full statement (159 words)
The Reliance LXPEDU IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems 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. Additional supplemental fixation is not necessary for the Lumbar IBF-S if the integrated screws are implanted.
The Reliance LXPEDU IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181118: Reliance Lumbar 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/K181118
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