510(k) · Cleared
ClearedChoice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choice Spine, Llp · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 2, 2009 after a 160-day review. The FDA summary names no predicate by number. 361 later devices descend from it.
- Decided
- Nov 2, 2009
- Review
- 160 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
361 later devices descend from it, 5 citing it directly.
- This deviceK091531 Choice Spine Cervical Interbody Spacer System Choice Spine Cervical…Choice Spine, Llp · 2009
- Descendant · cites it directly · 225 of its ownK101171 Orthovita Peek SpacerOrthovita, Inc. · 2011
- Descendant · 2 generations on · 224 of its ownK120486 Avs as Peek SpacerStryker Spine · 2012
- Descendant · cites it directly · 212 of its ownK120345 Honour Spacer SystemNexxt Spine, LLC · 2012
- Descendant · 3 generations on · 161 of its ownK142251 AVS AS PEEK SpacerStryker Corporation · 2014
- Descendant · 2 generations on · 145 of its ownK171140 Matrixx SystemNexxt Spine, LLC · 2017
Showing 5 of 361 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 361 · See all- K101171Orthovita Peek SpacerOrthovita, Inc. · 2011 · cites it directly225descendants
- K120486Avs as Peek SpacerStryker Spine · 2012 · 2 generations on224descendants
- K120345Honour Spacer SystemNexxt Spine, LLC · 2012 · cites it directly212descendants
- K142251AVS AS PEEK SpacerStryker Corporation · 2014 · 3 generations on161descendants
- K171140Matrixx SystemNexxt Spine, LLC · 2017 · 2 generations on145descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091531 | Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody… | Choice Spine, Llp | 2009 | — |
| +1 | K101171 | Orthovita Peek Spacer | Orthovita, Inc. | 2011 | — |
| +2 | K120486 | Avs as Peek Spacer | Stryker Spine | 2012 | — |
| +1 | K120345 | Honour Spacer System | Nexxt Spine, LLC | 2012 | — |
| +3 | K142251 | AVS AS PEEK Spacer | Stryker Corporation | 2014 | — |
| +2 | K171140 | Matrixx System | Nexxt Spine, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 10 | 0 |
| 2015 | 2 | 0 |
| 2016 | 8 | 0 |
| 2017 | 12 | 0 |
| 2018 | 13 | 0 |
| 2019 | 20 | 0 |
| 2020 | 37 | 0 |
| 2021 | 29 | 0 |
| 2022 | 44 | 0 |
| 2023 | 46 | 0 |
| 2024 | 40 | 0 |
| 2025 | 50 | 0 |
| 2026 | 44 | 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?
The FDA summary names no predicate by number.
What descends from it? (361)
See all 3615 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?
- Of its descendants, K101171 (Orthovita, Inc., 2011) has gone furthest, with 225 descendants of its own.
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. 2009, 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 Choice Spine Cervical Interbody Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is to be used with supplemental fixation and with autograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091531 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091531: Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091531
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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