# K261353: Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Kyocera Medical Technologies, Inc.
- Decided: Jul 15, 2026 after 82 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: 27 generations back to K841189 (1984). 643 ancestors in all.
No later device cites it as a predicate yet.
1 of 644 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212980: Tesera-k ALIF System, Kyocera Medical Technologies, Inc. (2022) Summary page 6.
- K222554: EL CAPITAN Anterior Lumbar Interbody Fusion, Astura Medical (2023) Summary page 6.
- K242771: Tesera-k PL System and Tesera-k XL System, Kyocera Medical Technologies, Inc. (2025) Summary page 6.

## Indications for use
The Kyocera Medical Technologies, Inc. (KMTI) Lumbar Anchor System is indicated for use with the KMTI Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System and Tesera-K XL System. The KMTI Tesera-K ALIF System is indicated for interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI Tesera-K ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non- operative treatment. Tesera-K SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-K SA ALIF cages are intended to be used with the coverplate and screws provided or with the KMTI Lumbar Anchor System. Tesera- K SA ALIF assemblies (cage, lumbar anchors, screws and coverplate) featuring one or more lumbar anchors are considered non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine. The coverplate assembly is required to be used if any anchors are implanted. Tesera-K SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-K SA ALIF cages are intended to be used with the coverplate and screws provided. Tesera-K SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles less than 20° and use all four screws are standalone and require no supplemental fixation. Tesera-K SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles greater than or equal to 20° or if the surgeon chose to use fewer than four screws are considered non standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine. The Kyocera Medical Technologies, Inc. (KMTI) Tesera-K XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Tesera-K XL System implants are to be used with autogenous or allogenic bone graft. Patients should be skeletally mature and have at least six weeks 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 additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K261353
Methodology: https://510kreport.com/methodology