# K192026: Peridot Intervertebral body fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Gbs Commonwealth Co., Ltd.
- Decided: Nov 26, 2019 after 120 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: 19 generations back to K841189 (1984). 321 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 328 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151140: LnK Lumbar Interbody Fusion Cage System, L&K BIOMED Co., Ltd. (2015) Summary page 4.
- K092193: Spinal Usa Interbody Cages, Spinal USA (2009) Summary page 4.
- K153783: SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF, Spinevision S.A. (2016) Summary page 4.
- K110927: Mectalif, Medacta International (2011) Summary page 4.
- K161379: ELSA Spacers, Globus Medical, Inc. (2016) Summary page 4.
- K151214: ALIF Interfixated System, Nu Vasive, Incorporated (2015) Summary page 5.
- K161230: NuVasive Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 5.

## Most influential descendants
- 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
- K232822: 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), 2 descendants of its own
- K233839: Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system (2023), 1 descendant of its own

## Indications for use
Peridot Intervertebral body fusion 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-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Peridot Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K192026
Methodology: https://510kreport.com/methodology