# K121178: Transcorp Acif System

- Pathway: 510(k) (Special)
- Applicant: Transcorp, Inc.
- Decided: Jul 5, 2013 after 443 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: 8 generations back to K841189 (1984). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092794: Transcorp Acif System, Transcorp, Inc. (2010) Summary page 2.
- K081730: Novel Cervical Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 2.
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 2.

## Indications for use
The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DOD) of the cervical spine at one disc level. DD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the 03 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

Source page: https://510kreport.com/device/K121178
Methodology: https://510kreport.com/methodology