510(k) · Cleared
ClearedAdvantage-C PEEK Cervical lnterbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lntelivation, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Aug 24, 2021 as substantially equivalent to K111983 (Zimmer Trabecular Metal Technology, 2011) and 2 other predicates after a 102-day review. Its family tree reaches back 15 generations to 1984. 1 later device descends from it.
- Decided
- Aug 24, 2021
- Review
- 102 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K841189 (1984). 84 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK112664 Zavation Ibf SystemsZavation, LLC · 2011
- 2 generations backK120576 Zavation Ibf SystemZavation, LLC · 2012
- 1 generation backK162206 Zavation IBFZavation, LLC · 2017
- This deviceK211501 Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC · 2021
- Descendant · cites it directly · 0 of its ownK252711 Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies · 2026
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 backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 7 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 6 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 5 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 4 generations backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
- 3 generations backK112664 Zavation Ibf SystemsZavation, LLC · 2011
- 2 generations backK120576 Zavation Ibf SystemZavation, LLC · 2012
- 1 generation backK162206 Zavation IBFZavation, LLC · 2017
- This deviceK211501 Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies · 2026 · cites it directly0descendants
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 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −7 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −6 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −5 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −4 | K110843 | Aleutian Spacer System | K2m, Inc. | 2011 | — |
| −3 | K112664 | Zavation Ibf Systems | Zavation, LLC | 2011 | — |
| −2 | K120576 | Zavation Ibf System | Zavation, LLC | 2012 | — |
| −1 | K162206 | Zavation IBF | Zavation, LLC | 2017 | — |
| 0 (this device) | K211501 | Advantage-C PEEK Cervical lnterbody Fusion Device | Lntelivation, LLC | 2021 | — |
| +1 | K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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 |
|---|---|---|---|
| * | K111983 | Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxSummary page 4…21 CFR §888.3080 (ODP) Class II E. Predicate Device: Zimmer-Biomet Vista®-S PEEK Cervical Cage System, K111983 (Primary) Zimmer-Biomet Vista®-S PEEK Cervical Cage System, K133784 F. Reference Predicate Device: Zavatio… | 2011 |
| * | K133784 | Vista-S Device, Associated InstrumentationSummary page 4…lass II E. Predicate Device: Zimmer-Biomet Vista®-S PEEK Cervical Cage System, K111983 (Primary) Zimmer-Biomet Vista®-S PEEK Cervical Cage System, K133784 F. Reference Predicate Device: Zavation Interbody Fusion System (IBF), K162206 G. Physical Description: The… | 2014 |
| * | K162206 | Zavation IBFSummary page 4…K111983 (Primary) Zimmer-Biomet Vista®-S PEEK Cervical Cage System, K133784 F. Reference Predicate Device: Zavation Interbody Fusion System (IBF), K162206 G. Physical Description: The proposed Intelivation Advantage-C Cervical Interbody Fusion Device is a sterile, single… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device | 2026 | 0 |
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 37 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 84 ancestors have a recall of any class.
- Of its descendants, K252711 (Intelivation Technologies, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K111983.
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. 2021, 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 Advantage-C PEEK Cervical Interbody Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with / without radicular symptoms at one level from C2 - T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Advantage-C PEEK Cervical Interbody Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft.. The Advantage-C PEEK Cervical Interbody Fusion Device is supplied sterile and is intended for one-time use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211501: Advantage-C PEEK Cervical lnterbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211501
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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