# K161608: InterForm Cervical Interbody Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Next Orthosurgical
- Decided: Sep 30, 2016 after 112 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The InterForm Cervical Interbody Cage System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The device is intended to be implanted via an open, anterior approach and used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Cervical Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the cervical spine. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device.

Source page: https://510kreport.com/device/K161608
Methodology: https://510kreport.com/methodology