# K182608: Oyster ACIF Cage

- Pathway: 510(k) (Traditional)
- Applicant: Silony Medical GmbH
- Decided: Jun 13, 2019 after 265 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: 17 generations back to K841189 (1984). 135 ancestors in all.
No later device cites it as a predicate yet.
1 of 136 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162587: Roccia® Acif, Silony Medical GmbH (2017) Summary page 5.
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 5.

## Indications for use
The Oyster ACIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster ACIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster ACIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K182608
Methodology: https://510kreport.com/methodology