510(k) · Cleared
ClearedReliance Cervical Ibf System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliance Medical Systems, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on May 8, 2012 as substantially equivalent to K081730 (Alphatec Spine, Inc., 2008) and 2 other predicates after a 90-day review. Its family tree reaches back 10 generations to 1984. 25 later devices descend from it.
- Decided
- May 8, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K841189 (1984). 34 ancestors in all. 25 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- This deviceK120396 Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2012
- Descendant · cites it directly · 24 of its ownK131429 Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013
- Descendant · cites it directly · 23 of its ownK142269 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015
- Descendant · cites it directly · 16 of its ownK172489 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017
- Descendant · cites it directly · 15 of its ownK173102 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017
- Descendant · 2 generations on · 6 of its ownK212358 Romero Cervical CageSpineup, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 4 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- This deviceK120396 Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2012
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013 · cites it directly24descendants
- K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015 · cites it directly23descendants
- K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017 · cites it directly16descendants
- K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017 · cites it directly15descendants
- K212358Romero Cervical CageSpineup, Inc. · 2022 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −4 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −3 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K073177 | Pioneer Intervertebral Fusion Device System | Pioneer Surgical Technology | 2008 | 1 |
| 0 (this device) | K120396 | Reliance Cervical Ibf System | Reliance Medical Systems, LLC | 2012 | — |
| +1 | K131429 | Reliance Cervical Ibf System | Reliance Medical Systems, LLC | 2013 | — |
| +1 | K142269 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2015 | — |
| +1 | K172489 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017 | — |
| +1 | K173102 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017 | — |
| +2 | K212358 | Romero Cervical Cage | Spineup, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 ODP? 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 |
|---|---|---|---|
| * | K081730 | Novel Cervical Spinal Spacer SystemSummary page 1…ODP Substantial Equivalence The Reliance Cervical IBF is substantially equivalent to the legally marketed Alphatec NOVEL Cervical System (K08 1730), the Pioneer Cervical IBF System (K073 177), and the Zimmer BAKIC Cage (P980048). The Reliance Cervical IBF is equivalent to the… | 2008 |
| * | K073177 | Pioneer Intervertebral Fusion Device SystemSummary page 1…ial Equivalence The Reliance Cervical IBF is substantially equivalent to the legally marketed Alphatec NOVEL Cervical System (K08 1730), the Pioneer Cervical IBF System (K073 177), and the Zimmer BAKIC Cage (P980048). The Reliance Cervical IBF is equivalent to these commercially available devices in terms o… | 2008 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…IBF is substantially equivalent to the legally marketed Alphatec NOVEL Cervical System (K08 1730), the Pioneer Cervical IBF System (K073 177), and the Zimmer BAKIC Cage (P980048). The Reliance Cervical IBF is equivalent to these commercially available devices in terms of material, intended use, levels of a… | 2001 |
What descends from it? (25)
See all 255 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 34 ancestors have a recall of any class.
- Of its descendants, K131429 (Reliance Medical Systems, LLC, 2013) has gone furthest, with 24 descendants of its own.
- 15 other devices also cite its predicate K081730.
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. 2012, 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 RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patienits. 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. The RELIANCE CERVICAL IBF System is intended for use at one level in the…
Read the full statement (123 words)
The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patienits. 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.
The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to TI, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE 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/K120396 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120396: Reliance Cervical Ibf System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120396
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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