# K242928: Tesera-k SC System

- Pathway: 510(k) (Traditional)
- Applicant: Kyocera Medical Technologies, Inc.
- Decided: Apr 10, 2025 after 198 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: 25 generations back to K841189 (1984). 419 ancestors in all.
No later device cites it as a predicate yet.
1 of 420 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223105: Tesera-K SC System, Kyocera Medical Technologies, Inc. (2022) Summary page 6.

## 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/K242928
Methodology: https://510kreport.com/methodology