# K242771: Tesera-k PL System and Tesera-k XL System

- Pathway: 510(k) (Traditional)
- Applicant: Kyocera Medical Technologies, Inc.
- Decided: Mar 20, 2025 after 188 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 26 generations back to K841189 (1984). 609 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 611 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172816: TiGer Shark™ System, Choicespine, LP (2018) Summary page 6.
- K133614: Aleutian Ibf System, K2m, Inc. (2014) Summary page 6.
- K172341: NuVasive® Modulus TLIF Interbody System, Nu Vasive, Incorporated (2017) Summary page 6.
- K181655: Renovis S180 Lateral Lumbar Interbody Fusion System, Renovis Surgical Technologies (2018) Summary page 6.
- K212980: Tesera-k ALIF System, Kyocera Medical Technologies, Inc. (2022) Summary page 6.

## Most influential descendants
- K261353: Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System (2026), 0 descendants of its own

## Indications for use
The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k PL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to S1. KMTI Teresa-K PL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k PL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine. The Kyocera Medica l Technologies, Inc. (KMTI) Tesera-k XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to S1. KMTI Tesera-k XL System implants arare to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k XL System is a non-standalone system and is required to be used with a dditiona l supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K242771
Methodology: https://510kreport.com/methodology