# K232619: MATRIX HA PEEK Cervical IBF System

- Pathway: 510(k) (Special)
- Applicant: Sapphire Medical Group
- Decided: Mar 19, 2024 after 203 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: 1 generation back to K192316 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192316: Matrix HA PEEK Cervical Implant System, Sapphire Medical Group (2019) Summary page 4.

## Indications for use
The Matrix HA PEEK Cervical Implant System is intended for spinal fusion procedures at multiple contiguous levels (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Matrix HA PEEK cervical implant system is intended to be used with a supplemental fixation system. Additionally, the use of hyperlordotic devices (lordotic angle greater than 80) are intended to be used exclusively with anterior supplemental fixation.

Source page: https://510kreport.com/device/K232619
Methodology: https://510kreport.com/methodology