# K172674: Sapphire Cervical Implant System

- Pathway: 510(k) (Special)
- Applicant: Sapphire Medical Group
- Decided: Nov 2, 2017 after 58 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.
9 later devices descend from it; 1 cites it directly.
0 of 10 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
- K181115: CxHA PEEK Cervical IBF System (2018), 8 descendants of its own
- K220875: HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (2022), 4 descendants of its own
- K231899: HAtetracell™-C Titanium Cervical IBF System (2023), 2 descendants of its own
- K222041: CYGNUS-C Standalone ACIF System (2023), 1 descendant of its own
- K262025: Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (2026), 0 descendants of its own

## Indications for use
The Cervical Implant 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 implanted via an open, anterior approach and packed with autogenous bone graft. The Cervical Implant is intended to be used with supplemental fixation system.

Source page: https://510kreport.com/device/K172674
Methodology: https://510kreport.com/methodology