510(k) · Cleared
ClearedAscential IBD PEEKc Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 15, 2016 as substantially equivalent to K142251 (Stryker Corporation, 2014) after a 56-day review. Its family tree reaches back 4 generations to 2009. 27 later devices descend from it.
- Decided
- Jul 15, 2016
- Review
- 56 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K091531 (2009). 5 ancestors in all. 27 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK091531 Choice Spine Cervical Interbody Spacer System Choice Spine Cervical…Choice Spine, Llp · 2009
- 3 generations backK101171 Orthovita Peek SpacerOrthovita, Inc. · 2011
- 2 generations backK120486 Avs as Peek SpacerStryker Spine · 2012
- 1 generation backK142251 AVS AS PEEK SpacerStryker Corporation · 2014
- This deviceK161407 Ascential IBD PEEKc SpacerStryker Spine · 2016
- Descendant · cites it directly · 22 of its ownK181246 Zavation IBF SystemZavation Medical Products, LLC · 2018
- Descendant · 2 generations on · 13 of its ownK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
- Descendant · 2 generations on · 9 of its ownK202398 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021
- Descendant · 2 generations on · 9 of its ownK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- Descendant · 2 generations on · 8 of its ownK200084 Zavation IBF SystemZavation Medical Products, LLC · 2020
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K181246Zavation IBF SystemZavation Medical Products, LLC · 2018 · cites it directly22descendants
- K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019 · 2 generations on13descendants
- K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021 · 2 generations on9descendants
- K202305Zavation IBF SystemZavation Medical Products, LLC · 2020 · 2 generations on9descendants
- K200084Zavation IBF SystemZavation Medical Products, LLC · 2020 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K091531 | Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody… | Choice Spine, Llp | 2009 | — |
| −3 | K101171 | Orthovita Peek Spacer | Orthovita, Inc. | 2011 | — |
| −2 | K120486 | Avs as Peek Spacer | Stryker Spine | 2012 | — |
| −1 | K142251 | AVS AS PEEK Spacer | Stryker Corporation | 2014 | — |
| 0 (this device) | K161407 | Ascential IBD PEEKc Spacer | Stryker Spine | 2016 | — |
| +1 | K181246 | Zavation IBF System | Zavation Medical Products, LLC | 2018 | — |
| +2 | K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2019 | — |
| +2 | K202398 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2021 | — |
| +2 | K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| +2 | K200084 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K142251 | AVS AS PEEK SpacerSummary page 4…ation device and Number 21 CFR §888.3080 Product Code ODP Predicate Devices Primary Predicate: AVS® AS PEEK Spacer (K142251) Device Description The Ascential IBD PEEKC Spacer is a hollow, ring-shaped PEEK Optima® LT1 implant… | 2014 |
What descends from it? (27)
See all 274 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 7 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K181246 (Zavation Medical Products, LLC, 2018) has gone furthest, with 22 descendants of its own.
- 5 other devices also cite its predicate K142251.
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. 2016, 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 Ascential IBD PEEKc Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous…
Read the full statement (128 words)
The Ascential IBD PEEKc Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.
The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161407 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161407: Ascential IBD PEEKc Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161407
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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