# K181471: ACCUFUSE Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Absolute Advantage Medical, LLC
- Decided: Aug 29, 2018 after 86 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: 4 generations back to K971730 (1997). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133218: Crystal ®; Mosaic ®; Vertu ®, Spinal Elements, Inc. (2014) Summary page 4.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 4.
- K082273: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2008) Summary page 4.
- K100070: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2010) Summary page 4.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 4.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.

## Indications for use
The ACCUFUSE Cervical System (intervertebral body fusion device) is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACCUFUSE Cervical System implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACCUFUSE Cervical System implants are to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to surgery. The ACCUFUSE Cervical System (cervical plate/screws) is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: •degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), •spondylolisthesis, •trauma (i.e. fractures or dislocations), •tumors, •deformity (defined as kyphosis, lordosis, or scoliosis), •pseudarthrosis, •failed previous fusion, •spinal stenosis

Source page: https://510kreport.com/device/K181471
Methodology: https://510kreport.com/methodology