# K120840: Lexus Cervical Intervertebral Body Fusion Cage System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: May 24, 2012 after 65 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 11 generations back to K841189 (1984). 45 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 1.
- K091873: Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-S, Spineart (2009) Summary page 1.
- K080401: Shell Cage, Wave Cage, Loop Cage, Advanced Medical Technologies AG (2008) Summary page 1.
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K143360: LnK Cervical Interbody Fusion Cage System (2015), 9 descendants of its own
- K151677: LnK Cervical Interbody Fusion Cage System (2015), 8 descendants of its own
- K202872: Prase PEEK Anterior Cervical Interbody Spacer (2021), 5 descendants of its own
- K213980: Peridot Spinal Interbody System (2022), 4 descendants of its own
- K230708: Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) (2023), 3 descendants of its own

## Indications for use
LEXUS Cervical Intervertebral body Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LEXUS Cervical Intervertebral body Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LEXUS Cervical Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K120840
Methodology: https://510kreport.com/methodology