# K192316: Matrix HA PEEK Cervical Implant System

- Pathway: 510(k) (Special)
- Applicant: Sapphire Medical Group
- Decided: Oct 17, 2019 after 52 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K232619: MATRIX HA PEEK Cervical IBF System (2024), 0 descendants of its own

## Indications for use
The Matrix HA PEEK Cervical Implant System is intended for spinal fusion procedures at one level (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.

Source page: https://510kreport.com/device/K192316
Methodology: https://510kreport.com/methodology