# K143450: Ackermann Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Ackermann Instrumente GmbH
- Decided: Sep 16, 2015 after 288 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: 13 generations back to K841189 (1984). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142347: Amedica Valeo II Interbody Fusion Device, Amedica Corp. (2014) Summary page 5.
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System, Aesculap Implant Systems, Inc. (2009) Summary page 5.
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space, Aesculap Implant Systems, Inc. (2008) Summary page 5.

## Indications for use
When used as a cervical intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device c|spine implants are indicated for spinal fusion procedures in skeletally mature patients. Cervical interbody fusion implants are intended for use at one level in the cervical spine, from C2 to T1, for treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. Additionally, the c|spine implants are to be used with autogenous bone graft and supplemental fixation via an open, anterior approach. When used as a lumbar intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device t|spine implants are indicated for spinal fusion procedures in skeletally mature patients. Lumbar interbody fusion implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for treatment of lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. The t|spine implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may be implanted via a transforaminal approach. These implants are to be used with autogenous bone graft and supplemental fixation.

Source page: https://510kreport.com/device/K143450
Methodology: https://510kreport.com/methodology