# K152532: AERO -C Cervical Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Dec 18, 2015 after 106 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K841189 (1984). 54 ancestors in all.
145 later devices descend from it; 3 cite it directly.
0 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142251: AVS AS PEEK Spacer, Stryker Corporation (2014) Summary page 4.
- K120486: Avs as Peek Spacer, Stryker Spine (2012) Summary page 4.
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 4.
- K072981: Synthes Zero-P, Synthes Spine Co.Lp (2008) Summary page 4.
- K150053: STALIF C; STALIF C-Ti, Centinel Spine, Inc. (2015) Summary page 4.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 4.

## Most influential descendants
- K171496: Tritanium C Anterior Cervical Cage (2017), 129 descendants of its own
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device (2019), 102 descendants of its own
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (2020), 81 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K152532
Methodology: https://510kreport.com/methodology