# K030809: Hanson Medical Gluteal Implant

- Pathway: 510(k) (Traditional)
- Applicant: Hanson Medical, Inc.
- Decided: Apr 21, 2003 after 39 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- 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) Hanson Medical Silicone Carving Block: named in the summary without a submission number
- (no number) Gluteal Implants made by AART, Inc: named in the summary without a submission number
- (no number) Gluteal Implants made by Silimed LLC: named in the summary without a submission number

## Indications for use
The Hanson Medical Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery. The Hanson Gluteal Implant will be carvable, allowing the physician to customize the device shape for muscular defects.

Source page: https://510kreport.com/device/K030809
Methodology: https://510kreport.com/methodology