# K181585: JGH1 Core Deccompression Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: AgNovos Healthcare USA, LLC
- Decided: Jul 20, 2018 after 35 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The JGHl Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the JGHl Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

Source page: https://510kreport.com/device/K181585
Methodology: https://510kreport.com/methodology