# K982040: Medpor Surgical Granule Implants

- Pathway: 510(k) (Traditional)
- Applicant: Porex Surgical, Inc.
- Decided: Sep 8, 1998 after 90 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- 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. The FDA summary names its predicate without a number.
- (no number) Other MEDPOR® implants manufactured and sold by Porex Surgical Inc.: named in the summary without a submission number
- (no number) INTERPORE IP 200 Granular Coralline Hydroxyapatite Bone Void Fillers: named in the summary without a submission number

## Indications for use
MEDPOR® Surgical Granule implants are intended for the augmentation or restoration of contour in the cranial facial area. They are indicated for use where a well formed pocket can be formed for containment, and where, because of the irregularity of the deformity, it is difficult to fill with other shaped implants. This material is intended exclusively for non-load bearing applications.

Source page: https://510kreport.com/device/K982040
Methodology: https://510kreport.com/methodology