510(k) · Cleared
ClearedAERO -C Cervical Cage System
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 Dec 18, 2015 as substantially equivalent to K142251 (Stryker Corporation, 2014) and 5 other predicates after a 106-day review. Its family tree reaches back 11 generations to 1984. 145 later devices descend from it.
- Decided
- Dec 18, 2015
- Review
- 106 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K841189 (1984). 54 ancestors in all. 145 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- This deviceK152532 AERO -C Cervical Cage SystemStryker Spine · 2015
- Descendant · cites it directly · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 2 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- Descendant · 3 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 5 generations on · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- This deviceK152532 AERO -C Cervical Cage SystemStryker Spine · 2015
Showing 5 of 145 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 145 · See all- K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · cites it directly129descendants
- K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 2 generations on106descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 3 generations on104descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 4 generations on102descendants
- K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc. · 2020 · 5 generations on81descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −5 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −4 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −3 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −2 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −1 | K102606 | Avs Anchor-C Cervical Cage System | Stryker Spine | 2011 | 1 |
| 0 (this device) | K152532 | AERO -C Cervical Cage System | Stryker Spine | 2015 | — |
| +1 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +2 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| +3 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| +4 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| +5 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 12 | 0 |
| 2022 | 14 | 0 |
| 2023 | 18 | 0 |
| 2024 | 26 | 0 |
| 2025 | 28 | 0 |
| 2026 | 28 | 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? (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 |
|---|---|---|---|
| * | K142251 | AVS AS PEEK SpacerSummary page 4…ly equivalent to the devices listed below: Primary Predicate x Stryker Spine AVS® AS PEEK Spacer, K142251 & K120486 Additional Predicates x… | 2014 |
| * | K120486 | Avs as Peek SpacerSummary page 4…below: Primary Predicate x Stryker Spine AVS® AS PEEK Spacer, K142251 & K120486 Additional Predicates x Stryker Spine AVS® Anchor-C Cervic… | 2012 |
| * | K102606 | Avs Anchor-C Cervical Cage SystemSummary page 4…Additional Predicates x Stryker Spine AVS® Anchor-C Cervical Cage System, K102606 x ORTHOVITA PEEK Cages, K072981 x Surgicraft STALIF C®, K150053… | 2011 |
| * | K072981 | Synthes Zero-PSummary page 4…Predicates x Stryker Spine AVS® Anchor-C Cervical Cage System, K102606 x ORTHOVITA PEEK Cages, K072981 x Surgicraft STALIF C®, K150053 x Synthes Zero-P, K072981 x… | 2008 |
| * | K150053 | STALIF C; STALIF C-TiSummary page 4…Anchor-C Cervical Cage System, K102606 x ORTHOVITA PEEK Cages, K072981 x Surgicraft STALIF C®, K150053 x Synthes Zero-P, K072981 x LDR Spine ROI-C System, K091088… | 2015 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 4…ages, K072981 x Surgicraft STALIF C®, K150053 x Synthes Zero-P, K072981 x LDR Spine ROI-C System, K091088 Reference Devices… | 2009 |
| † | K133328 | Aero-AL Lumbar Cage System | 2014 |
| † | K142066 | Aero-LL Lumbar Cage System | 2014 |
What descends from it? (145)
See all 1453 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 31 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 54 ancestors have a recall of any class.
- Of its descendants, K171496 (Stryker Spine, 2017) has gone furthest, with 129 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. 2015, 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 AERO®-C Cervical Cage is 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-Tl disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy. The AERO®-C Cervical…
Read the full statement (139 words)
The Stryker Spine AERO®-C Cervical Cage is 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-Tl disc.
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The AERO®-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The AERO®-C Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. In addition, the device must be used with the included fixation anchors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152532: AERO -C Cervical Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152532
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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