# K030808: Hanson Medical Calf 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) Calf Implants made by AART, Inc: named in the summary without a submission number
- (no number) Calf Implants made by Slimed LLC: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K030808
Methodology: https://510kreport.com/methodology