# K083118: Spinal Usa Anterior Cervical Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: May 27, 2009 after 217 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: 1 generation back to K073351 (2008). 2 ancestors in all.
458 later devices descend from it; 2 cite it directly.
0 of 461 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081730: Novel Cervical Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 1.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K160125: Cascadia Interbody System (2016), 315 descendants of its own

## Indications for use
The Spinal USA Interbody Fusion Device ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Spinal USA Interbody Fusion Device ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

Source page: https://510kreport.com/device/K083118
Methodology: https://510kreport.com/methodology