# K110733: Daytona Anterior Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Spinenet, LLC
- Decided: Aug 25, 2011 after 162 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P980048 (2001). 3 ancestors in all.
481 later devices descend from it; 5 cite it directly.
0 of 485 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- K082260: Integra Cervical and Petra Plif Lumbar Cages, Calvary Spine, LLC (2008) Summary page 1.

## Most influential descendants
- K123206: Maxim Surgical X-Treme Interbody Fusion System (2013), 454 descendants of its own
- K140003: Coroent Small Interbody System (2014), 453 descendants of its own
- K142050: Nuvasive Coroent Small Contoured Interbody System (2014), 449 descendants of its own
- K140921: Coroent Small Interbody System (2014), 444 descendants of its own
- K150362: NuVasive CoRoent Small Interbody System (2015), 441 descendants of its own

## Recalls of this device
- Feb 5, 2013 · Class II · Z-2103-2013: The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product mark

## Indications for use
The Daytona Anterior Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine with accompanying radicular symptoms at one disc level. ODD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These ODD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Daytona Anterior Cervical Cage System is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to Ti disc levels using autograft bone. The Daytona Anterior Cervical Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K110733
Methodology: https://510kreport.com/methodology