# K232292: Peridot-EX Expandable Intervertebral Body Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Gbs Commonwealth Co., Ltd.
- Decided: Nov 7, 2023 after 98 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). 628 ancestors in all.
No later device cites it as a predicate yet.
1 of 629 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193258: ProLift Expandable System, Life Spine, Inc. (2020) Summary page 4.
- K210800: IO Expandable Lumbar Interbody Fusion System, MiRus, LLC (2021) Summary page 4.
- K142498: MAGNIFY and MAGNIFY-S Spacers, Globus Medical, Inc. (2015) Summary page 4.
- K222554: EL CAPITAN Anterior Lumbar Interbody Fusion, Astura Medical (2023) Summary page 4.
- K161379: ELSA Spacers, Globus Medical, Inc. (2016) Summary page 4.
- K213755: Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system, Gbs Commonwealth Co., Ltd. (2023) Summary page 4.
- K190762: The JASPER Spinal Fixation System II, Gbs Commonwealth Co., Ltd. (2019) Summary page 6.

## Indications for use
The Peridot-EX Expandable 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 and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems and anterior screw and rod systems). The Peridot-EX Expandable Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage. Hyperlordotic interbody devices (> 20° lordosis) must be used with at least anterior supplemental fixation.

Source page: https://510kreport.com/device/K232292
Methodology: https://510kreport.com/methodology