# K213980: Peridot Spinal Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Gbs Commonwealth Co., Ltd.
- Decided: Mar 15, 2022 after 85 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: 21 generations back to K841189 (1984). 345 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 350 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192026: Peridot Intervertebral body fusion System, Gbs Commonwealth Co., Ltd. (2019) Summary page 4.
- K202872: Prase PEEK Anterior Cervical Interbody Spacer, Gbs Commonwealth Co., Ltd. (2021) Summary page 4.
- K163491: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2017) Summary page 5.

## Most influential descendants
- 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
- K243915: FIX-C 3D Ti ACIF System (2025), 0 descendants of its own

## Indications for use
The Peridot Cervical Spinal Interbody System are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. The Peridot Cervical Spinal Interbody system are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to faciliate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. The Peridot Lumbar Spinal Interbody system are 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. The Peridot Lumbar Spinal Interbody system are 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/K213980
Methodology: https://510kreport.com/methodology