510(k) · Cleared
ClearedCervical Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Additive Implants, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jan 28, 2019 as substantially equivalent to K160125 (K2m, 2016) and 5 other predicates after a 140-day review. Its family tree reaches back 20 generations to 1984. 1 of the 239 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- Jan 28, 2019
- Review
- 140 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 20 generations to K841189 (1984). 223 ancestors in all, the oldest K792352 (1979). 15 later devices descend from it, 1 citing it directly. 1 of the 239 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 2 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 1 generation backK160125 Cascadia Interbody SystemK2m · 2016
- This deviceK182477 Cervical SpacerAdditive Implants, LLC · 2019
- Descendant · cites it directly · 14 of its ownK193359 SureMAX Family of Cervical SpacersAdditive Implants, Inc. · 2020
- Descendant · 2 generations on · 10 of its ownK202666 CONSTRUX Mini PTC Spacer SystemOrthofix, Inc. · 2020
- Descendant · 2 generations on · 9 of its ownK203342 CONSTRUX Mini Ti Spacer SystemOrthofix, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 6 of its ownK202949 CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK211704 CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System…Orthofix, Inc. · 2021
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 backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 2 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 1 generation backK160125 Cascadia Interbody SystemK2m · 2016
- This deviceK182477 Cervical SpacerAdditive Implants, LLC · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 15 · See all- K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc. · 2020 · cites it directly14descendants
- K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc. · 2020 · 2 generations on10descendants
- K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc. · 2021 · 2 generations on9descendants
- K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc. · 2020 · 2 generations on6descendants
- K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc. · 2021 · 3 generations on5descendants
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 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −2 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −1 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| 0 (this device) | K182477 | Cervical Spacer | Additive Implants, LLC | 2019 | — |
| +1 | K193359 | SureMAX Family of Cervical Spacers | Additive Implants, Inc. | 2020 | — |
| +2 | K202666 | CONSTRUX Mini PTC Spacer System | Orthofix, Inc. | 2020 | — |
| +2 | K203342 | CONSTRUX Mini Ti Spacer System | Orthofix, Inc. | 2021 | 1 |
| +2 | K202949 | CONSTRUX Mini PEEK Spacer System | Orthofix, Inc. | 2020 | — |
| +3 | K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini… | Orthofix, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 14 | 0 |
| 2004 | 24 | 0 |
| 2005 | 15 | 0 |
| 2006 | 6 | 0 |
| 2007 | 11 | 0 |
| 2008 | 35 | 1 |
| 2009 | 19 | 0 |
| 2010 | 10 | 0 |
| 2011 | 15 | 0 |
| 2012 | 9 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 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.
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? (6)
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 |
|---|---|---|---|
| * | K160125 | Cascadia Interbody SystemSummary page 5…plants are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F3001, Grade 23). Primary Predicate: Cascadia Interbody System (K2M Inc. – K160125) Additional Predicates: ALTA Anterior Cervical Interbody Spacer (Astura Medical – K173324), Novel Syst… | 2016 |
| * | K173324 | ALTA Anterior Cervical Interbody SpacerSummary page 5…01, Grade 23). Primary Predicate: Cascadia Interbody System (K2M Inc. – K160125) Additional Predicates: ALTA Anterior Cervical Interbody Spacer (Astura Medical – K173324), Novel System (Alphatec Spine Inc. – K081730), MC+ (LDR Holding – K091088), BA… | 2018 |
| * | K081730 | Novel Cervical Spinal Spacer SystemSummary page 5…Inc. – K160125) Additional Predicates: ALTA Anterior Cervical Interbody Spacer (Astura Medical – K173324), Novel System (Alphatec Spine Inc. – K081730), MC+ (LDR Holding – K091088), BAK/C Interbody Fusion System (Centerpulse - SpineTech, Inc.… | 2008 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 5…Cervical Interbody Spacer (Astura Medical – K173324), Novel System (Alphatec Spine Inc. – K081730), MC+ (LDR Holding – K091088), BAK/C Interbody Fusion System (Centerpulse - SpineTech, Inc. – P980048), SynCage-C (Synthes Spine – K0… | 2009 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 5…atec Spine Inc. – K081730), MC+ (LDR Holding – K091088), BAK/C Interbody Fusion System (Centerpulse - SpineTech, Inc. – P980048), SynCage-C (Synthes Spine – K024364) Performance Data: Mechanical testing of the worst case Cervical Spacer included stat… | 2001 |
| * | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow)Summary page 5…Holding – K091088), BAK/C Interbody Fusion System (Centerpulse - SpineTech, Inc. – P980048), SynCage-C (Synthes Spine – K024364) Performance Data: Mechanical testing of the worst case Cervical Spacer included static and dynam… | 2003 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193359 | SureMAX Family of Cervical Spacers | 2020 | 14 |
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 · 4 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 10 months on median.
- 27 of the 223 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K193359 (Additive Implants, Inc., 2020) has gone furthest, with 14 descendants of its own.
- 20 other devices also cite its predicate K160125.
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?
The Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Cervical Spacer is to be used…
Read the full statement (106 words)
The Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Cervical Spacer is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182477: Cervical Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182477
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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