# K153250: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies
- Decided: Mar 16, 2016 after 128 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 14 generations back to K841189 (1984). 93 ancestors in all.
32 later devices descend from it; 5 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102547: Coroent Interlock System, Nuvasive, Inc. (2011) Summary page 4.
- K072981: Synthes Zero-P, Synthes Spine Co.Lp (2008) Summary page 5.
- K072415: Stalif (TM) C, Surgicraft, Ltd. (2008) Summary page 5.

## Most influential descendants
- K173077: Cavetto-SA Cervical Cage System (2018), 21 descendants of its own
- K200115: Cavetto-SA Cervical Cage System (2020), 19 descendants of its own
- K212853: Cervical Stand-Alone System (2021), 18 descendants of its own
- K181621: Stable-C Interbody System (2018), 7 descendants of its own
- K231763: Stable-C Interbody System (2023), 6 descendants of its own

## Indications for use
The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (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 Anterior Cervical Fusion (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 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 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/K153250
Methodology: https://510kreport.com/methodology