510(k) · Cleared
ClearedRepublic Spine Restore Cervical Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Republic Spine, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jun 19, 2019 as substantially equivalent to K090064 (Eminent Spine, 2009) and 2 other predicates after a 75-day review. Its family tree reaches back 22 generations to 1984. 1 of the 322 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 19, 2019
- Review
- 75 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K841189 (1984). 321 ancestors in all. No later device cites it as a predicate yet. 1 of the 322 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 backK162138 NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated · 2016
- 2 generations backK172676 NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK183397 ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP · 2019
- This deviceK190889 Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC · 2019
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 backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 4 generations backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
- 3 generations backK162138 NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated · 2016
- 2 generations backK172676 NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK183397 ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP · 2019
- This deviceK190889 Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC · 2019
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
View 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 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −4 | K160916 | CoRoent® Ti-C System | Nu Vasive, Incorporated | 2016 | — |
| −3 | K162138 | NuVasive CoRoent Small Ti-C System | Nu Vasive, Incorporated | 2016 | — |
| −2 | K172676 | NuVasive® Modulus-C Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K183397 | ChoiceSpine Stealth Cervical Spacer System | Choicespine, LP | 2019 | — |
| 0 (this device) | K190889 | Republic Spine Restore Cervical Interbody Fusion System | Republic Spine, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 16 | 0 |
| 2004 | 23 | 0 |
| 2005 | 19 | 0 |
| 2006 | 9 | 0 |
| 2007 | 14 | 0 |
| 2008 | 40 | 1 |
| 2009 | 29 | 0 |
| 2010 | 22 | 0 |
| 2011 | 27 | 0 |
| 2012 | 15 | 0 |
| 2013 | 16 | 0 |
| 2014 | 21 | 0 |
| 2015 | 10 | 0 |
| 2016 | 8 | 0 |
| 2017 | 3 | 0 |
| 2018 | 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.
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 |
|---|---|---|---|
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 5…190889 Page 2 of 2 Primary Predicate Eminent Spine Copperhead (K090064) Additional Predicate(s) Zavation IBF (K181246) Choice Spine (K183397) Reference Device(s) Republic… | 2009 |
| * | K181246 | Zavation IBF SystemSummary page 5…Page 2 of 2 Primary Predicate Eminent Spine Copperhead (K090064) Additional Predicate(s) Zavation IBF (K181246) Choice Spine (K183397) Reference Device(s) Republic Spine (K150283) Substantial The basi… | 2018 |
| * | K183397 | ChoiceSpine Stealth Cervical Spacer SystemSummary page 5…Page 2 of 2 Primary Predicate Eminent Spine Copperhead (K090064) Additional Predicate(s) Zavation IBF (K181246) Choice Spine (K183397) Reference Device(s) Republic Spine (K150283) Substantial The basis of substantial equivalence of the subject dev… | 2019 |
| † | K150283 | Republic Spine Dark Star Spinal System | 2015 |
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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 14 companies; a new generation was cleared every 11 months on median.
- 38 of the 321 ancestors have a recall of any class; 1 has a Class I recall.
- 33 other devices also cite its predicate K090064.
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. 2019, 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?
When used as a cervical intervertebral body fusion device, the Republic Spine Restore Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190889 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190889: Republic Spine Restore Cervical Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190889
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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