# K182007: Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies
- Decided: Dec 7, 2018 after 133 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- 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). 216 ancestors in all.
No later device cites it as a predicate yet.
1 of 217 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153250: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System, Renovis Surgical Technologies (2016) Summary page 4.
- K181655: Renovis S180 Lateral Lumbar Interbody Fusion System, Renovis Surgical Technologies (2018). Cleared while this submission was under review Summary page 4.

## Indications for use
The Renovis Tesera SC Stand-alone ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone ACF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The Renovis Tesera SC Stand-alone ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability. The Renovis Tesera C ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera C ACF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The Renovis Tesera C ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

Source page: https://510kreport.com/device/K182007
Methodology: https://510kreport.com/methodology