# K223105: Tesera-K SC System

- Pathway: 510(k) (Traditional)
- Applicant: Kyocera Medical Technologies, Inc.
- Decided: Dec 22, 2022 after 83 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: 24 generations back to K841189 (1984). 418 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 424 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212853: Cervical Stand-Alone System, Eminent Spine, LLC (2021) Summary page 5.
- K211111: SureMAX-SA Cervical Standalone System, Additive Implants, Inc. (2021) Summary page 5.
- K173077: Cavetto-SA Cervical Cage System, Neurostructures, Inc. (2018) Summary page 5.
- K153250: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System, Renovis Surgical Technologies (2016) Summary page 5.

## Most influential descendants
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K250486: Skyway Anterior Cervical Plate System (2025), 1 descendant of its own
- K261451: ZSAlign Cervical Interbody System (2026), 0 descendants of its own
- K242928: Tesera-k SC System (2025), 0 descendants of its own

## Indications for use
The KMTI Tesera-K SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-K SC 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 KMTI Tesera-K SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of two (2) bone screws and the locking bolt. When used without the locking bolt and two screws, the KMTI Tesera-K SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.

Source page: https://510kreport.com/device/K223105
Methodology: https://510kreport.com/methodology