# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Gbs Commonwealth Co., Ltd.
- Decided: May 22, 2023 after 69 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: 23 generations back to K841189 (1984). 421 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 425 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210497: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System, SeaSpine Orthopedics Corporation (2021) Summary page 4.
- K213980: Peridot Spinal Interbody System, Gbs Commonwealth Co., Ltd. (2022) 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 5.
- K200551: MectaLIF Transforaminal TiPEEK, Medacta Inernational SA (2021) Summary page 5.

## Most influential descendants
- 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
Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) The Peridot-TD Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with 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 multiple contiguous levels from C2-T1. The Peridot-TD Anterior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment. The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system) The Peridot-TD 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. The Peridot-TD 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.

Source page: https://510kreport.com/device/K230708
Methodology: https://510kreport.com/methodology