510(k) · Cleared
ClearedAvs as Peek 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 Aug 20, 2012 as substantially equivalent to K101171 (Orthovita, Inc., 2011) after a 185-day review. Its family tree reaches back 2 generations to 2009. 224 later devices descend from it.
- Decided
- Aug 20, 2012
- Review
- 185 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K091531 (2009). 224 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK091531 Choice Spine Cervical Interbody Spacer System Choice Spine Cervical…Choice Spine, Llp · 2009
- 1 generation backK101171 Orthovita Peek SpacerOrthovita, Inc. · 2011
- This deviceK120486 Avs as Peek SpacerStryker Spine · 2012
- Descendant · cites it directly · 161 of its ownK142251 AVS AS PEEK SpacerStryker Corporation · 2014
- Descendant · cites it directly · 145 of its ownK152532 AERO -C Cervical Cage SystemStryker Spine · 2015
- Descendant · 2 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 3 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- Descendant · 4 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
Showing 5 of 224 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 224 · See all- K142251AVS AS PEEK SpacerStryker Corporation · 2014 · cites it directly161descendants
- K152532AERO -C Cervical Cage SystemStryker Spine · 2015 · cites it directly145descendants
- K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 2 generations on129descendants
- K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 3 generations on106descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 4 generations on104descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K091531 | Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody… | Choice Spine, Llp | 2009 | — |
| −1 | K101171 | Orthovita Peek Spacer | Orthovita, Inc. | 2011 | — |
| 0 (this device) | K120486 | Avs as Peek Spacer | Stryker Spine | 2012 | — |
| +1 | K142251 | AVS AS PEEK Spacer | Stryker Corporation | 2014 | — |
| +1 | K152532 | AERO -C Cervical Cage System | Stryker Spine | 2015 | — |
| +2 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +3 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| +4 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 11 | 0 |
| 2020 | 16 | 0 |
| 2021 | 18 | 0 |
| 2022 | 24 | 0 |
| 2023 | 32 | 0 |
| 2024 | 32 | 0 |
| 2025 | 36 | 0 |
| 2026 | 35 | 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 |
|---|---|---|---|
| * | K101171 | Orthovita Peek Spacer | 2011 |
What descends from it? (224)
See all 2247 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142251 | AVS AS PEEK Spacer | 2014 | 161 |
| K152532 | AERO -C Cervical Cage System | 2015 | 145 |
| K162496 | Foundation 3D Interbody | 2017 | 82 |
| K132991 | C-Box Peek Cervical Ibf | 2014 | 9 |
| K141129 | Exactech Cervical Spacer System | 2014 | 8 |
| K253151 | Fule Interbody Fusion Cage System | 2026 | 0 |
| K132483 | Innesis Peek Cervical Cage | 2014 | 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 3 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142251 (Stryker Corporation, 2014) has gone furthest, with 161 descendants of its own.
- 1 other device also cites its predicate K101171.
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. 2012, 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 Stryker Spine AVS® AS PEEK 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 C1-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and implanted via an open, anterior approach.
The AVS® AS PEEK Spacers are 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/K120486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120486: Avs as Peek Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120486
Report an extraction error
Are you the manufacturer?
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