# K212980: Tesera-k ALIF System

- Pathway: 510(k) (Traditional)
- Applicant: Kyocera Medical Technologies, Inc.
- Decided: Jan 7, 2022 after 112 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: 25 generations back to K841189 (1984). 520 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 523 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193320: KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System, Kyocera Medical Technologies, Inc. (2020) Summary page 4.
- K200879: SeaSpine Meridian System, SeaSpine Regatta Lateral System, SeaSpine Orthopedics Corporation (2020) Summary page 5.
- K190483: SPIRA Open Matrix ALIF and LLIF, Camber Spine Technologies (2019) Summary page 5.
- K131612: Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif Peek Cages, GS Medical Co., Ltd. (2014) Summary page 5.
- K092193: Spinal Usa Interbody Cages, Spinal USA (2009) Summary page 5.
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019) Summary page 5.

## Most influential descendants
- K242771: Tesera-k PL System and Tesera-k XL System (2025), 1 descendant of its own
- 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 Anterior Lumbar Interbody Fusion (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 nonoperative treatment. The Tesera-k ALIF System implants are available in standalone (Tesera-k SA) and non-standalone (Tesera-k A) configurations. 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. Tesera-k A ALIF cages are monolithic and do not interface or mate with any additional implants. Tesera-k A ALIF cages may be implanted from direct anterior or oblique insertion angle. Tesera-k A ALIF cages are non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K212980
Methodology: https://510kreport.com/methodology