# K202872: Prase PEEK Anterior Cervical Interbody Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Gbs Commonwealth Co., Ltd.
- Decided: Feb 4, 2021 after 129 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: 20 generations back to K841189 (1984). 331 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 337 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151677: LnK Cervical Interbody Fusion Cage System, L&K BIOMED Co., Ltd. (2015) Summary page 4.
- K192026: Peridot Intervertebral body fusion System, Gbs Commonwealth Co., Ltd. (2019) Summary page 4.
- K200592: GS Medical AnyPlus PEEK Cage System, GS Medical Co., Ltd. (2020) Summary page 4.

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

## Indications for use
Prase PEEK Anterior Cervical Interbody Spacer 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. Prase PEEK Anterior Cervical Interbody Spacer is used to facilitate intervertebral body fusion in the cervical spine from the C3 to C7 disc levels using autograft bone. Prase PEEK Anterior Cervical Interbody Spacer 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/K202872
Methodology: https://510kreport.com/methodology